Analytical Scientist Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the analytical scientist job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

B Marquardt

Bridgette

Marquardt

50850 Denesik Loaf

Boston

+1 (555) 378 8239

50850 Denesik Loaf

Boston

Phone

p +1 (555) 378 8239

Experience Experience

Houston, TX

Analytical Scientist

Houston, TX

Berge and Sons

Houston, TX

Analytical Scientist

Providing high quality documentation of all technical work performed in the laboratory
Perform personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations
Provide technical expertise, support and troubleshooting in the development and validation of analytical methods working across the technical teams
Develop and manage analytical competencies to support various Research & Development programs, manufacturing divisions and technical service requests
Provide cross functional sharing of data to aid in project development
Establish, develop, and/or optimize bioanalytical methodology to test and quantify process impurities in biopharmaceutical products
Establish, develop, and/or optimize analytical methodology to test the identity and concentration of impurities (product-related and process-related)

Boston, MA

R&D Analytical Scientist

Boston, MA

Larkin-Hirthe

Boston, MA

R&D Analytical Scientist

Provide technical support to QC in trouble‐shooting on existing analytical methods
Provide analytical support to formulation group in order to finalize the formulation composition and components for new products
Assist in the general operation of the Analytical R&D laboratory, including maintenance of SOP's, training and equipment validation or maintenance
Commitment to maintaining a safe work environment and following all company EHS procedures
Develop familiarity with basic laboratory equipment (operation, raw data processing, and calibration)
Perform Identification studies for unknowns in drug products using Raman, LC/MS, GC/MS, Raman etc
Analytical method development

present

Los Angeles, CA

Senior Analytical Scientist

Los Angeles, CA

Rogahn, Denesik and Zulauf

present

Los Angeles, CA

Senior Analytical Scientist

present

Work with other senior analysts to lead the analytical laboratory operation and identify opportunities for improvements in working practices and procedures
Provide expert input to projects in the analytical chemistry department
Responsible for nutrients /contaminant test method development and method transfer to third party and laboratories within Abbott
Ensure analytical team’s delivery to project’s portfolio of the centre from early stage to product development
Assist in the analysis of data generated by organizations external to MS&T
Perform data analysis to support documents for submission to regulatory agencies
Perform training and method transfer from R&D to the QC team

Education Education

Bachelor’s Degree in Biology

Michigan State University

Bachelor’s Degree in Biology

Skills Skills

Have good hands-on ability and be a quick learner
Knowledgeable in applied quality control methods including SPC, control charting, gage R&Rs, statistical DoE, and root cause analysis
Knowledgeable in applied quality control methods including SPC, control charting, gage R&Rs, statistical DoE, and root cause analysis
Capability to apply analytical techniques for characterization and stability-indicating of therapeutic biologics in formulation and process development
Highly proficient with lab instrumentation and test methods (i.e. FTIR, HPLC, ICG, GC, UV-Vis, Nitrogen Analyzer, NIR and NMR)
Solid knowledge of cGMP and GDP
Ability to organize, keep detailed documentation and records, and achieve timely, accurate results
Industry relevant experience; 5 to 8 years of experience in pharmaceutical or biotech company is highly desirable
Knowledge of analytical techniques which can be applied to assess properties and stability of biologics
Strong analytical and problem solving ability

Create a Resume in Minutes

15 Analytical Scientist resume templates

Read our complete resume writing guides

Senior Analytical Scientist Resume Examples & Samples

40 %: Designs, manages and executes analytical methods for (includes internal and external execution) to support commercial programs, manufacturing investigations, assay remediation and assay development
40%: Participate and represent Analytical MS&T group in various cross functional meetings
20%: Review manufacturing and assay documents (internal and external sources) and results to ensure technical excellence and compliance with regulatory guidelines. Assess/communicate progress to supervisor and key stakeholders within and outside the group

Principal Analytical Scientist Resume Examples & Samples

60% - Analytical Subject Matter Expert
In support of product development, apply broad and deep analytical knowledge and experience to the material characterization and testing of APIs and drug products
Leverage fundamental understanding of formulations, product development, and material characterization to implement analytical methodologies as appropriate for various formulations and dosage forms
Author and/or review analytical methods and associated development, qualification, validation and transfer protocols and reports
Manage and oversee stability and analytical studies for projects. This includes authoring / reviewing protocols and reports as well as evaluating the results and leading technical discussions with project team members and external contractors
Ensure all cGMP data generated for development projects are managed and evaluated as described in relevant internal procedures and regulatory requirements
Effectively communicate complex technical issues and deliver concise presentations to management and non-technical stakeholders
Provide technical input for selecting external Shire contractors and manage day-to-day contractor activities for respective projects
Serve as a peer-leader to motivate / inspire colleagues and to mentor others in various aspects of analytical and problem-solving methodologies
Maintain a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses
20% - Regulatory Submissions
Assist with responses to regulatory agencies regarding stability and analytical-related inquiries
20% - Documentation / Compliance
Ensure analytical test methods, development reports, and specifications are compliant with internal procedures and regulatory requirements
Assist in the development and implementation of departmental processes, procedures and policies
Maintain adherence to departmental and quality systems, such as SOP training records, deviations/investigations, CAPAs, and Change Controls

Analytical Scientist Resume Examples & Samples

Design and execution of structure/function studies to enhance understanding of CQAs and contribute to a comprehensive analytical package for IND and BLA submissions
Conduct laboratory-based analytical method development and characterization activities; coordinating CRO activities
Technical documentation including authorship of sections for regulatory filings
Internal and external presentations
Evaluation of new technologies to drive efficiency and innovation
Enhance department technical capability
Contribute to strategy and planning through participation in project teams
Holistic understanding of protein structure/function relationships and experience designing approaches for elucidating structures and mechanisms using a wide range of methodologies
Expertise with electrophoresis methods, with focus on capillary separation and/or microfluidics is preferred
Expertise in conceptualizing, developing, and troubleshooting complex assays is required, for example methods to determine charge profile (e.g., iCE, IEX, and CZE) or PTMs (e.g., peptide mapping, LC/MS, glycan profiling)
Experience working with external collaborators or CROs is preferred
Experience with visualization of data and hypothesis testing using statistical software (e.g., JMP) is preferred

Senior Principal Analytical Scientist Resume Examples & Samples

Under the direction of the Pharmaceutical Analysis (PA) Director, the Associate Director is responsible for supporting global product development within the Pharmaceutical Sciences (PS) department. This position is for a high level, experienced analytical professional to serve as an analytical subject matter expert and point of contact for Shire’s product development group (for synthetic APIs in a 100% outsourced model). The candidate must have deep and broad expertise in analytical chemistry in support of active pharmaceutical ingredient (API) and drug product development. The candidate will leverage their direct analytical experience to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects
This is an individual contributor role in which the candidate represents the PA group on multiple cross-functional project teams where they provide analytical expertise, associated regulatory support, and manage the analytical aspects of the projects. This requires significant internal collaboration as well as the management of analytical activities conducted at external Contract Research Organizations (CROs)
As needed, the Associate Director will deputise for the PA Director during meetings involving various Shire functions such as Regulatory Affairs, Quality Assurance, Technical Operations, and R&D management
60%: Analytical Subject Matter Expert
Apply knowledge and direct experience to ensure the appropriate analytical methodologies are in place and fit-for-purpose to properly support the development projects
Provide technical guidance for troubleshooting / investigating complex issues regarding analytical, stability, and process / product development
Apply statistical analysis for interpretation of analytical and stability data
Author and/or review release, in-process and stability specifications for APIs and drug products
Quickly and effectively resolve complex analytical issues and deviations / investigations
Actively contribute to the preparation and coordination of internal audits and regulatory inspections
Create and enhance collaborative and trusting relationships internally and with personnel at Contract Research Organizations (CROs)
20%:Regulatory Submissions
Author and/or review relevant API and drug product CMC sections for global regulatory submissions (IND/CTA and NDA/MAA and annual reports) and ensure sections meet submission ready standards regarding content and format
Maintain awareness of current trends regarding global regulatory CMC requirements through literature and conference attendance
20%: Documentation / Compliance
Supervise / coach less experienced staff as needed
Requires an advanced degree (MS or PhD) in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 8 years of relevant analytical experience within the Pharmaceutical Industry
The following items are essential
Direct experience with the analytical support of synthetic APIs and drug products
Strong knowledge of ICH and other regulatory guidelines
Knowledge and experience with product development and clinical supplies processes
Experience in authoring analytical-related CMC sections of IND/IMPD and NDA/MAA regulatory submissions
Experience working with Contract Research Laboratories
Proven experience with various quality systems (e.g. investigations / deviations, CAPAs, change controls, etc.)
The following items are preferred
Knowledge and experience with statistical applications for data evaluation
Knowledgeable in European and US CMC regulatory requirements for APIs and drug products
Familiarity with MHRA / FDA inspections and compliance experience

Senior Analytical Scientist MS&T Resume Examples & Samples

Responsible for supporting commercial biologic programs, manufacturing investigations, assay remediation and assay development
Define analytical strategy for commercial programs supporting CMC filings and process characterization; which include and are not limited to: interacting/interfacing with quality, regulatory, manufacturing, process development organizations and CMOs/CROs
Assist and take lead role in manufacturing investigations; which include and are not limited to: being analytical team member, developing the analytical strategy and methods, coordinate sampling and testing (either internally or externally), assessment of results and communicating results to team
Assist in assay remediation and assay development; participate in team meetings, develop and execute analytical plan, timelines, compile data and communicate results to team. Planning and evaluation of new (or replacement) technology/methods to support manufacturing or product release
Assist in the analysis of data generated by organizations external to MS&T
Perform data analysis to support documents for submission to regulatory agencies
MS with 10+ years of experience or a PhD with 5+ years of experience with analytical development of protein therapeutics and analysis of polymers and small molecules
Have experience in interacting with and understanding of manufacturing, process development and quality (control and assurance) aspects to assure compliant operations

Bio Analytical Scientist Resume Examples & Samples

Experience running HPLC
Minimum of 1 year Industry experience
Capillary Eletrophresis experience

Senior Analytical Scientist Resume Examples & Samples

60% Conduct laboratory experiments to develop phase-appropriate methods for process development and product characterization
20% Technical documentation, e.g., protocols, reports, sections for regulatory submissions
Experience with developing and implementing approaches for identifying & elucidating structures and/or mechanisms is required

Analytical Scientist Resume Examples & Samples

Identification, development and validation of analytical methods
Identification and implementation of new technology supporting assignments/projects
Write test methods, development/validation of protocols and reports
Provide technical expertise, support and troubleshooting in the development and validation of analytical methods working across the technical teams
Support the transfer of analytical methods to other laboratories and sites
Actively participate within cross functional teams to ensure technical progress and issues are communicated effectively and in a timely fashion
Strong compliance/quality focus as well as with attention to quality by design to develop robust methods
BSc in Science or related degree
Minimum 3 years' experience
Knowledge of analytical chemistry; and quality guidelines
Excellent problem solving, method development and validation skills

Principal Analytical Scientist Resume Examples & Samples

60% Analytical Subject Matter Expert
20% Regulatory Submissions
20% Documentation / Compliance

Analytical Scientist Resume Examples & Samples

Has the ability to gather and review resources and select and synthesize data for reports and other written materials
Has good literature search skill and good ability to write reviews
Good ability of communicate effectively in both oral and written forms
Excellent time management and organizational skills needed to handle and balance multiple projects simultaneously and changing priorities
Ability to work independently and within a team environment
Ability to independent and innovative thinking, strong responsibility, self-motivated and cooperative

Packaging Analytical, Scientist Resume Examples & Samples

Support Atlanta Packaging Engineering Technology Center
Perform routine and non-routine packaging physical performance evaluation, conduct material characterization including chemical and thermal/mechanical testing on packaging and packaging materials
New testing method development/validation and establishment of new capabilities
Maintain analytical instruments and ensure turn-around time and test result reliability
Perform new instrument installation, software operation, method setup, troubleshooting, and data processing
Maintain test request database and achieving test results
Stay current with industry trends on latest packaging testing technologies and capabilities
Perform packaging physical performance testing using instrumental methods in order to determine packaging performance
Perform thermal/mechanical analyses using instrumental methods in order to determine the material properties
Working with senior engineers and scientists to evaluate and validate existing test methods; and to develop new test methods
Interpret data from routine and non-routine analyses in order to validate that ingredients/materials meet specifications and approve for shipment to Company plants
Purchase laboratory supplies to maintain proper level of inventory
Instrumental Analysis: Ability to measure packaging dimension and evaluate packaging physical performance using laboratory instruments
Proprietary Composition Information: Ability to recognize and protect proprietary information as it relates to formulas, ingredients and design
Basic engineering principles and technical skills: Knowledge of analytical engineering tools and other techniques. It also includes understanding new developments in the field and their effect on our packaging performance
Databases/Data Acquisition: Knowledge of and ability to use technical databases (e.g., scientific, medical). Ability to understand and apply hardware and software used in the collection of technical data in a laboratory or field environment

Data Analytical Scientist Resume Examples & Samples

Drive the Data Strategy and align it with continuously to changing business landscape
Work on all data types across the enterprise including Customer, Dealer, and Vehicle, Manufacturing, PD and Quality functions
Support the data requirements of the different functional teams
Evaluate, explore and select the right data platform technologies including Big Data, RDBMS & NoSQL to meet the analytics requirements
Provide visibility to Data Quality issues and work with the business owners to fix the issues
Implement an Enterprise Data Governance model and actively promote the concept of data sharing, data reuse, data quality and data standards
Perform any necessary data mapping, data lineage activities and document information flows
Build the Metadata model & Business Glossary by gathering information from multiple sources: business users, existing data sources, databases and other relevant documents and systems
Serve as data subject matter expert and demonstrate an understanding of key data management principles and data use
Drive Master Data Management(MDM) strategy including implementing the governance model for Master Data
Drive Data profiling and data exploration for basic understanding and profiling of the data
3+ years of experience in data design, data architecture and data modeling (both transactional and analytic)
3+ years of experience in Big Data technologies (Hadoop, MapReduce, pig, Hive, Shark, Spark, Scoop) developing/executing shell scripts to move large amount of data
Experience creating scripts to manipulate files within HDFS
Knowledge of data transfer and ingestion technologies
Experience building visualizations using Tableau/Qlikview
Ability to write complex SQL queries needed to query & analyze data
Knowledge of data management standards, data governance practices, and data quality
Ability to communicate complex solution concepts in simple terms
Ability to apply multiple solutions to business problem
Ability to quickly comprehend the functions and capabilities of new technologies
Strong analytical and problem solving skills, with the ability to communicate in a clear and succinct manner and effectively evaluates information / data to make decisions
Strong interpersonal, and leadership skills, with proven abilities to communicate complex topics to leaders and peers in a simple, clear, plan oriented manner
Ford or automotive experience preferred

R&D Senior Analytical Scientist Resume Examples & Samples

Provide technical direction within the team
Perform a range of analysis including texture analysis, rheological testing, particle sizing, solid fat content, moisture analysis, density measurements, differential scanning colorimetry, colour measurements, ash content, total fat analysis and basic microscopy analysis, independently
Perform method development in consultation with colleagues at the analytical hub sites where samples are non transportable
Perform maintenance and troubleshooting of lab equipment
Expert user of specific software and proficient in the use of generic and specific software packages required for the role
Provide training and supervise junior staff in routine activities and methods and interpretation
Work as part of an efficient analytical team both at site level and globally
To liase with clients, analytical technical specialists and line management in other locations to ensure effective communication of project proposals and results
To maintain relations with technical stakeholders and clients
Plan routine projects for junior staff
Train junior members of the team as required
Locally support a team of scientists
Write and approve SOPs and Test Methods
Generation and approval of Risk Assesments and COSHH
Own the analytical train the trainer programme for Wroclaw R&Q and ensure training records are accurate and up to date
Unveristy dergree in a relevant scientific discipline and with relevant experience in a laboratory
Extended experience of working in relevant area
Scientific understanding and ability to independently conduct chemical analysis in relevant area
Analytical Project management expeience
Flexible and adaptable
Good command of English, both written and oral

Analytical Scientist Resume Examples & Samples

Set up Drug mixing and Analytical Lab testing capability on site
Draft Lab operating and testing procedures. These will include chemical compounding, finished Product testing, and Drug Solution testing
Transfer test methods from existing laboratories in the US
Specification, Procurement, Installation, and Validation of Analytical & Mixing Lab Equipment and associated software packages
Daily monitoring and verification of laboratory equipment and completion of associated paperwork
Recruit, Train and Supervise Lab Technicians
Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards
Participates in new product/technology development and supports the QA activities as part of an overall project team
Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings
Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality
Develops and executes required validations in line with regulatory standards to include equipment, process and product validations
Conducts root cause analysis and implements corrective action in a timely manner
Comply with GLP/ GMP and safety requirements at all times
Maintain laboratories in a clean and well organised state at all times
Conducts audits, including closing out audit findings and creating and determining proper corrective and preventive action
Deals with suppliers and ensures their quality standards
An Engineering or Quality Assurance Degree or equivalent experience
A minimum of 3 years post qualification experience as a Quality Assurance Engineer or in another Science or Engineering related role within a Medical Device or regulated environment

Analytical Scientist Resume Examples & Samples

Design and develop analytical method as stability indicating method for biologics/biologics formulation to facilitate formulation development, process developments and commercial drug product monitoring
Apply analytical techniques and data trending analysis to define molecular properties as well as stability of biologics i.e. antibodies and antibody drug conjugates
Collaborate/support process engineers to design and conduct studies for commercial process development of drug product
Collaborate and provide support for analytical technology transfer
Authoring and presentation of study reports, technical reports and regulatory documents
Ability to design, execution and interpretation of studies to drive the optimization and performance of analytical methods
Ensure work and related activities are complied with all relevant Safety, Quality and Regulatory requirements
Master's Degree with 5 years working experience or Bachelor's Degree with 8 years working experience with background of Analytical Chemistry, Formulation, Biochemistry, Pharmaceutics or Pharmaceutical related Sciences
Analytical experience focusing on biologics or biologics formulation related topics; experience with antibodies, antibody drug conjugates is preferred
Hands-on analytical skills and problem-solving skills; Experience and knowledge of HPLC method development and application are preferred
Bench scientist-oriented with independent working ability
Ability of working in multi-disciplinary environment and communicating efficiently in a teamwork environment setting
Industry relevant experience; 5 to 8 years of experience in pharmaceutical or biotech company is highly desirable
Knowledge of analytical techniques which can be applied to assess properties and stability of biologics
Capability to apply analytical techniques for characterization and stability-indicating of therapeutic biologics in formulation and process development
Experience/ knowledge of formulations development for clinical and commercial use
Knowledge and experience for biologics stabilization is a plus
Experience or knowledge of drug development process, cGMP/ GMP compliance requirements and regulatory compliance will be a plus

Analytical Scientist Resume Examples & Samples

Experience with cGMP practices
Knowledge of routine sample testing of raw materials, cell culture media and cell culture samples
Knowledge of ICH guidance for Validation for analytical procedure :Q2R1
Experience with analytical methods development for characterization of raw materials, cell culture media and cell culture samples and understanding of method transfers, validations/qualification
Experience writing validation protocols/reports
Knowledge of USP/NF, Ph.Eur and JP compendia
Familiarity with ICP-MS
Experience with HPLC/UPLC (Agilent, Waters) and LC/MS instruments (Waters, Thermoscientific/Agilent)
Laboratory support for cell culture studies
Secondary Method training for ELL employee
ELN entries and review for compliance checking
Sample management support including inventory management, shipping and logistics
Proficiency in one or more of the following skills: : HPLC/UPLC including chelating chromatography methods for trace metal analysis,ICP-MS, Raman Spectroscopy, Fluorescense Spectroscopy, NOVA, Vicell, CeDex, BGA, cIEF, A280, SE-HPLC, Oligosaccharide methods, Raw Materials

Protein Analytical Scientist Resume Examples & Samples

Perform analysis of proteins with a variety of biochemical assays such as HPLC (size exclusion, reversed-phase, ion-exchange and HIC), mass spectrometry (MS), and/or capillary electrophoresis (CE)
Provide analytical development support to different functional groups
Prepare data for presentation and write technical reports
Perform review of analytical data
Troubleshoot methods and instrumentation problems as needed
Theoretical and practical understanding of protein chemistry, mass spectrometry and separation science
Ability to analyze, interpret, summarize and present data at group or department meetings is required
Hands-on experience in protein therapeutics characterization and LC-MS/MS is a plus
Experience in LC/MS operation, troubleshooting and routine instrument maintenance is a plus
Ability to work independently and as part of a team, self-motivation, adaptability, dependable, and with a positive attitude
Strong computer, scientific, planning and organizational skills
Bachelors or Master’s degree in Biochemistry, Chemistry, Analytical Chemistry with 3-5 years of related industry experience; or PhD with 0-2 years of related industry experience
Authorization to work in the United States indefinitely without restriction or sponsorship

Analytical Scientist Resume Examples & Samples

Conduct routine sample testing using HPLC, Capillary Electrophoresis, Mass Spec, and other techniques
Support the analysis of reference material and comparability assessment
Perform routine analytical testing in support of material release and stability to support the development of recombinant proteins and monoclonal antibody drugs
Characterization of charge and size profile of protein therapeutic molecules by mass spectrometry
Proficient using HPLC, UPLC, Mass Spec, and Capillary Electrophoresis systems and familiarity with EMPOWER and 32 Karat software
Background and understanding of protein science, characterization, and molecular biology
Ability to follow established protocols and procedures, and ability to develop new or revise existing protocols and procedures as needed
Strong technical writing that can be demonstrated through peer reviewed publications
Ability to work independently and as part of a team with internal and external clients, self‑motivation, adaptability, and a positive attitude
Excellent documentation skills, including an understanding of or experience with GLP/GMP requirements
B.S. or M.S. in Chemistry, Biochemistry, Analytical Sciences, or related scientific field and 1 to 3 years of relevant experience
Experience working with HPLC, CE, or mass spectrometry methods

Analytical Scientist Resume Examples & Samples

Perform analytical testing of medium to high complexity, drug product method development, and/or method verification using instrumentation including, but not limited to, HPLC, GC, UV spectrophotometer, dissolution equipment, Karl Fischer titrators
Write test protocols and document results
Make recommendations for technical improvements
Review notebooks and reports
Bachelor's or Master's degree in chemistry or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)

Analytical Scientist Resume Examples & Samples

Helps team with routine analysis which may involve Chromatography (Size exclusion, Reverse Phase), Capillary electrophoresis, UV measurements and viscosity measurements
Maintaining inventory of routine lab consumables
Leads the efforts to keep lab safe, de-cluttered and organized
Responsible for scheduling vendor visits for equipment repair or maintenance
Responsible for routine maintenance of equipment
Good judgment and escalation of technical issues in a timely manner
BS or MS in bioanalytical, biophysical, biochemistry, molecular/cell biology, or related field
1-4 years of relevant experience in analytical laboratories performing analysis of peptides, proteins and antibodies
Strong knowledge and background in performing HPLC (such as size exclusion and reverse phase) including HPLC and capillary electrophoresis
Excellent understanding of peptides, antibodies, proteins and associated degradation pathways
Ability to independently contribute from the bench (design and execute experiments)
Experience/ knowledge of parenteral formulations development
Well versed in handling computer software and hardware challenges
Understanding of protein chemistry, structure and conformation, as it relates to chemical and physical stability
Knowledge of experimental design and basic statistical analysis
Experience working with third party/ contract organizations

Analytical Scientist, In-process Testing Resume Examples & Samples

Leading Tech transfer, scale-up development and adaptation, control strategy implementation, process validation, comparability for Specialty Care biologics introduction at Sanofi and external Industrial sites
Owning process control strategy of licensed products and providing technical assistance and partnership to commercial manufacturing and QC at Sanofi and external sites including change assessment, process monitoring, troubleshooting and continuous improvement for drug substance
Degree in life sciences, engineering or other relevant discipline
Knowledge in antibody structure, function and characterization
Prior experience in analytical service coordination, sample management, SOP/LP documentation, and data track system
Commit to customers- Understands meet and exceed internal and external customer expectations
Act for Change – Drives a continuous improvement mindset & develops high levels of employee engagement #LI-GZ

Process Analytical Scientist, Upstream Resume Examples & Samples

Laboratory/pilot or manufacturing skills in upstream processing and associated analytical testing techniques
Knowledge of use of structured methodologies for upstream process design, process control strategies, validation and continuous process verification as applied to mammalian-expressed proteins
Act for Change – Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes #LI-GZ

Analytical Scientist Resume Examples & Samples

B.S. in Analytical Chemistry, Material Science, Paint and Coatings Engineering, or Chemical Engineering and 10+ yrs, or M.S. & 5-10 yrs, or Ph.D. & 3-5 yrs of industrial experience
Experience with standard ASTM, ISO coating environmental resistance testing standards: fog (salt, humidity, CASS); adhesion, etc
Understanding and knowledge of the main scientific root causes of the most important material surface properties: corrosion phenomena, oxidation phenomena, passivation, chemical resistance, mechanical properties such as hardness and scratch resistance
Method verification and validation experience
Strong computer base skills
Knowledgeable in regards to coating science and technology, including testing and application preferred

Analytical Scientist Resume Examples & Samples

B.S. in Optics, Optical Engineering, Physics, Electrical Engineering, Material Science, Analytical Chemistry, Paint and Coatings Engineering, Quality Engineering, or Chemical Engineering and 10+ yrs, or M.S. & 5-10 yrs, or Ph.D. & 3-5 yrs of industrial experience
Basic understanding of a broad range of spectroscopic techniques with experience using (UV-VIS-NIR) spectrophotometers, FTIR, colorimeters, haze meters, and gloss meters is required
Innovative problem solving skills and good prioritization skills
Strong computer base skills are required. Some programming experience such as Visual Basic in Excel is preferred
Working knowledge of thin films, optical glass, and microscopic material characterization techniques such as TEM, SEM, AFM and other spectroscopic techniques such as XRD, XRF, XPS, and Auger would be a plus
Knowledgeable in applied quality control methods including SPC, control charting, gage R&Rs, statistical DoE, and root cause analysis a plus

Analytical Scientist Resume Examples & Samples

Minimum of 3-5 years experience (ideal is 5-10 years) in chemical, environmental simulation and/or mechanical testing such as acid/base resistance, fog testing, corrosion testing, temperature-humidity cycling, xenon and UV weathering, brush testing, taber abrasion, scratch testing, etc
Strong computer base skills are required
Knowledgeable in applied quality control methods including SPC, control charting, gage R&Rs, statistical DoE, and root cause analysis

Analytical Scientist Resume Examples & Samples

Experience with the validation of associated ELISA based analytical methods
Knowledge of automated workstation equipment (i.e. Biomek 4000, Biomek NXp, plate washer etc.)
Possess sterile laboratory technique when performing cell/tissue culture and/or serological assays
Working knowledge of antibody purification
Ability to multi-task, prioritize, organize, schedule and perform a variety of serological/potency assays to provide clinical support to assigned projects
Assist others with project assignments
Prepares accurate detailed documents of experimental designs, protocols, procedures, presentations and reports
Transfer to end user new and/or revised serological assays
Provide cross functional sharing of data to aid in project development

Senior Analytical Scientist Resume Examples & Samples

Working within a QC team within a R&D organisation, carrying out all analytical activities required to deliver new respiratory products to clinical studies and commercialization
Lead the planning and execution of experiments to generate scientific understanding in development of analytical methods, formulations and processes
Perform analyses related to clinical supplies, stability, and process scale up
Process and review data, interpret results and report experimental outcomes to project development team
Lead the troubleshooting of instrumentation and investigation of aberrant sample results
Maintain laboratory documentation in accordance with cGMP documentation practices
Deputise for the QC team leader
Contribute to project delivery by carrying out other tasks (e.g. laboratory housekeeping, ordering, shipping samples) as required
Work with other senior analysts to lead the analytical laboratory operation and identify opportunities for improvements in working practices and procedures
Oversee the day-to-day work of less experienced analytical laboratory staff

Analytical Scientist Resume Examples & Samples

Developing fit-for-purpose analytical methods according to QbD principles for compounds from pre-clinical until commercial phases
Supporting API and DP process development
Validating analytical methods according to business and regulatory needs
Ensuring the smooth operation of LC-MS and GC-MS analyses for the above mentioned activities
Transferring the methods to relevant commercial QC units, including CRO's
Ensuring stability and clinical release testing in a GMP environment in order to support clinical trials
Providing high quality documentation of all technical work performed in the laboratory
Participating to the daily bench activities as well as supervising activities performed externally
Actively participating to project meetings as well as internal scientific meetings
Participating to the implementation of new state-of-the-art analytical methodologies and process improvements

Analytical Scientist Resume Examples & Samples

To harness good communication within the team and with other sections within the company and communicate / present on data within the team and other departments
Develops familiarity with basic and advanced laboratory equipment (operation, raw data processing, basic maintenance and calibration and qualification). Ensure equipment is maintained in accordance with cGMP requirements
To prepare and review basic and advanced area documentation (Laboratory notebooks, laboratory reagent logbook, SOPs, Protocols, Reports and Specification Sheets)
Must possess knowledge of quality procedures within a highly regulated pharmaceutical laboratory
Be able to work as a flexible analytical member of a stability team, Quality Orientated, Tight Deadline Awareness, Housekeeping Aware
Energy to achieve stretch goals
Track record of delivering of results and systems improvements
Excellent standard of laboratory documentation completion necessary

Analytical Scientist Resume Examples & Samples

Demonstrate solid knowledge in both the theoretical and practical aspects of analytical chemistry, especially quantitative analysis
Develop and maintain working knowledge of commonly used spectroscopic, chromatographic and wet chemistry procedures
Work with various analytical methods including cleaning verification, assay and impurities, dissolution, residual solvents for raw materials, in-process samples or finished products testing
Understand and conduct studies for method development/evaluation, validation, transfer and verification according to scientific justifications and current regulatory guidance (e.g., ICH, FDA, USP, EP, etc.)
Prepare and review technical documents, including validation/transfer/verification protocols and reports, analytical test procedures, technical reports, analytical investigations, etc. for review
Understand drug product formulations, manufacturing process and work closely with product development and process transfer teams on testing of product development and process validation batches and providing proper data interpretation as necessary
Provide training to QC analysts after methods are validated/transferred/verified
When necessary, perform routine quality control testing for raw materials, in-process samples and finished product for commercial manufacturing operations
Keep contemporary, accurate, legible, and complete experimental records in accordance with GMP and SOPs
Effectively communicate analytical results and potential issues with supervisors and necessary team members
Demonstrate strong skills/expertise/high proficiency on two or more specific analytical techniques. For instance troubleshooting of: HPLC or GC instrumental problems, dissolution methods, or related substance assays. High throughput, based on level of difficulty, in areas of proficiency is expected
Able to author / review SOP’s that fall within defined area of subject matter expertise
Takes personal ownership in work and takes responsibility for all elements of the assignments
Schedule daily tasks in an organized and efficient manner so that multiple activities run concurrently to meet project timelines
Ability to work independently and in a “flow to the work” team environment
In combination with other lab personnel, be responsible for a clean and safe working environment and take proactive corrective action when needed
Calibrate and maintain lab equipment and instrumentation as assigned
Perform peer review of analytical testing and write up as necessary
Maintain familiar with current, relevant scientific literature and technologies
Demonstrate a high level of professionalism, enthusiasm, dedication and productivity
A Bachelor’s Degree is required
A Bachelor’s Degree in science or related degree (Chemistry, Biology, Chemical Engineering or Life Sciences) is preferred
Ph.D, or M.S. in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry) is preferred
Experience in the pharmaceutical industry is preferred
At least 5 years pharmaceutical industry or 8 years of analytical testing/research experience using HPLC/GC/UV, etc. is preferred
Ability to perform analytical method research and development is required
Strong working experience with chromatographic (e.g., HPLC or GC) and spectroscopic (e.g., UV) analysis in candidate’s research work is required
Strong Technical writing skills are required
Understanding of analytical chemistry calculations such as concentrations (%, ppm, µg/mL, etc), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc. is required
Understanding of solubility, oxidation/reduction, acid/base hydrolysis, heat and photo degradation is required
Ability to perform basic statistical data analysis is required
Good laboratory notebook documentation skills and clear/legible handwriting is required
Good hands-on ability and be a quick learning skills are required
Ability to multi-task with high efficiency and work in a fast paced environment to meet deadlines is required
Ability to coordinate and prioritize to support manufacturing and project timelines is required
Ability to work well under pressure and maintain efficiency both on an individual and team basis is required
Ability to communicate effectively is required
Advanced knowledge and demonstrated performance in regards to all lab safety process and procedures and the ability to work safely with chemicals of varying potency is required
General computer literacy including use of Microsoft Word, Excel, and Power Point, etc. is required
Ability to perform analytical testing while standing for long periods of time is required
Accurate testing on the first attempt under pressure of production deadlines will be required
At least 5 years pharmaceutical industry or 8 years of analytical testing/research experience using HPLC/GC/UV, etc
Inspection of products, test results, and appropriately maintaining computerized documentation of required information
Laboratory Procedures
Safely perform testing required by position
Knowledge of and proper use of equipment
Safely handling chemicals and compounds
Regular cleaning of lab space as required
Coordination with other laboratory associates for maintaining safe environment
Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs
Maintaining clean environment for laboratory operations
Use of and safe handling of glass canisters, chemicals, and other required equipment
Coordination in a laboratory setting
Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking

Senior Analytical Scientist Resume Examples & Samples

B.S. Chemistry or Pharmaceutical Sciences and 5+ years of experience
M.S. Chemistry or Pharmaceutical Sciences and 2-3 years of experience
Ph.D Chemistry or Pharmaceutical Sciences 0-2 years of experience
Develop and maintain generic pharmaceutical products and serve as an R&D lead on ANDA/NDA projects through the following responsibilities
Perform physical and chemist testing on raw materials, packaging materials, in-process and finished proucts, and development batches and stability samples
Utilize following analytical equipment and techniques: HPLC, UPLC, GC, LC-MS, Dissolution, UV-VIS, IR, Titration. Author and execute EQ protocols and set up qualification program for new instruments
Method development and validation and author SOPs and technical documentation (including test methods, protocols, finished product specifications, etc.)
Prepare relevant documentation for ANDA/NDA regulatory filings
Assist with the training and oversight of junior staff in the R&D department

Analytical Scientist Resume Examples & Samples

Holds a professional scientific qualification: e.g. B.Sc. Hons Chemistry or equivalent
Evidence of the ability to perform / interpret data for a range of analytical techniques e.g HPLC and GC chromatography and IR, UV, Mass Spectroscopy and material testing
Has a working knowledge of the quality systems applicable to the design and quality assessment of medical devices e.g. BS EN 13485, method development, method validation, calibration, training and archiving. Practical experience of using these systems is desirable
Microsoft Office Suite: Word, PowerPoint, Excel, Outlook and Internet Explorer preferred

Analytical Scientist Resume Examples & Samples

Independently driving development projects within PDS
Plan, execute, analyze, document and present analytical studies for the characterization of pharmaceutical Products (NCEs)B
Development, validation and transfer of analytical methods
Perform bench work as required, 10-50%
Organizing / Conducting stability and release testing of clinical trial material according to cGMP guidelines
Summarizing results in technical reports and supporting the creation of submission related documents
Active participation in international project teams
Engineering / Master / Diploma degree in Chemistry, Pharmaceutical Sciences or equivalent; PhD is desirable
A minimum of 2 years’ industry experience
Sound scientific knowledge in various analytical techniques such as HPLC, GC, dissolution testing
Experience in the pharmaceutical industry is desirable
Good project management skills
Highly self-motivated and good team player
Very flexible and agile individual with high accountability
Excellent command of written and spoken English and German
Flexibility to travel within Europe (up to 20%)

Analytical Scientist Resume Examples & Samples

Dissolution testing
Safety and hazardous waste requirements
Data acquisition applications and databases
Demonstrated critical thinking ability with experience in conducting and writing laboratory investigations

Analytical Scientist Resume Examples & Samples

Laboratory operations, including safely and efficiently providing quantitative measurements using commercially available instruments
Consultation to and collaboration with DuPont scientists to provide solutions to problems in DuPont businesses through Elemental Analysis work done in-house and through Contract Analytical Lab partners
MS or Ph.D. in Chemistry, Materials Science, or Physics
Results oriented, with ability to solve problems
Strong networking skills and ability to learn independently
The ability to relate Elemental Analysis results to chemical and materials process steps
Ability to contribute or collaborate effectively in a cross-disciplinary team environment and lead a project/task team. Prior supervisory experience of lab operations is desirable

Analytical Scientist Resume Examples & Samples

Develops efficient and selective analytical procedures (with emphasis on HPLC, GC, GC-MS and LC-MS) for assigned projects
Prepares qualification and validation protocols and reports for analytical procedures and instrumentation
Prepares high quality written documentations (notebooks, SOPs, and analytical procedures) and assists with regulatory documentation
Troubleshoots analytical instrumentation
Communicates effectively in verbal and written form on research results and plans
Acts as a technical consultant for other staff at JMPS
Volunteers to assist with task not directly related to a specific project and independently applies scientific knowledge (both theoretical and practical) for the resolution of analytical challenges
Leads internal or external project, interacts with clients
Participates in self-development activities
Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc
Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers

Analytical Scientist Resume Examples & Samples

Establish, develop, and/or optimize bioanalytical methodology to test and quantify process impurities in biopharmaceutical products
Utilize experience in bioanalytical techniques such as CE-SDS and iCIEF to develop robust methods for use in QC GMP testing laboratories. Have working knowledge of ELISA and PCR techniques
Design, write, and review protocols for assay qualification/validation studies
Evaluate and make recommendations on new instrumentation and technology in the analysis of impurities
Transfer new or improved analytical methods to customer groups
Lead troubleshooting activities for established bioanalytical test methods (CE-SD, iCIEF) for process impurities used in development and release testing. Provide analytical support in troubleshooting process and formulation problems
Perform job duties with limited direction from supervisor. Design scientifically sound studies and experiments being given only a general outline of the study goal
Tabulate results and write summary reports of assay development and validation studies
Present findings at departmental and possibly at interdepartmental meetings
Using the available scientific literature, develop scientific arguments for white paper justifications and investigation conclusions
Produce and maintain accurate records
Train junior level group members and act as a mentor within the laboratory
Represent Analytical Sciences on interdepartmental teams and in meetings
Extensive knowledge of CE based assays, CE-SDS, iCIEF, and 2D Electrophoresis
Ability to prioritize, manage multiple tasks, and meet deadlines
Requires a PhD in Chemistry, Biochemistry, or Bioengineering; may consider another degree discipline. cGMP experience is strongly preferred
Level to be determined based on experience

Analytical Scientist Resume Examples & Samples

Excellent analytical skills with the ability to make sound suggestions or recommendations
Ability to work independently, often under time-sensitive situations, within a team environment
Excellent organization skills which includes the ability to execute several assignments simultaneously

Analytical Scientist Resume Examples & Samples

Independently develop analytical methods for drug substances, drug product, preservatives and degradation/impurities in the new drug products
Perform validation experiments as per approved method validation protocols, Company SOP and ICH guidelines
Perform in‐process, finished product/release and stability testing of dosage forms as per the approved methods
Perform Extractable/leachable studies for container closure systems of drug products
Perform analytical method transfer from R&D to QC laboratory for newly validated methods
Write/revise analytical methods, method validation protocols, method development and validation reports, method transfer protocols/reports, In‐vitro comparison reports etc
Perform calibration of analytical equipment as per approved procedures
Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGLPs and Company SOPs
Document all activities in the appropriate laboratory notebook as per SOPs and cGLPs
Assist in the general operation of the Analytical R&D laboratory, including maintenance of SOP's, training and equipment validation or maintenance
The successful candidate will hold a degree in Chemical or Life Sciences from an accredited university and wil have one to seven years' experience in analytical methods development in a small molecule product environment. A recent PhD with small molecule experience will be considered
Experience with analytical method development and reverse engineering for suspension and emulsion products desired

Analytical Scientist Resume Examples & Samples

Perform in-process, finished product/release and stability testing of dosage forms as per the approved methods
Write/revise analytical methods, method validation protocols, method development and validation reports, method transfer protocols/reports, In-vitro comparison reports etc
Provide technical support to QC in trouble-shooting on existing analytical methods
Assist in the general operation of the Analytical R&D laboratory, including maintenance of SOP’s, training and equipment validation or maintenance

Analytical Scientist Resume Examples & Samples

Minimum Master’s level degree in organic chemistry with at least 7 years post-graduate hands-on LC-MS and analytical laboratory experience
Deep, hands-on knowledge of LC-MS or tandem MS instrumentation, method development, and data interpretation
Knowledge of computerized data acquisition and analysis systems
Ability to work independently, and in a team, in a fast-paced, deadline-driven environment
Experience with LC-MS/MS techniques for proteomic, oligomer, dyes, and additives in polymers, plastics, elastomers, leathers, and textile
Minimum of 7 years of LC-MS/MS with method development/validation experience
Familiarized with Thermo Scientific Orbitrap –based system and in silicofragmentation software such as Mass Frontier or MetFrag

Analytical Scientist Lc-hrms Small Molecule Resume Examples & Samples

PhD level in analytical chemistry (or a related subject area) or 1st Degree qualification with >5 years industry-relevant experience in chemistry
Experience in LC-HRMS -based small molecules analysis and data processing resulting a thorough knowledge of concepts, principles, processes and methods
Track record in the application of mass spectrometry within biological systems including

Analytical Scientist Resume Examples & Samples

Conducts day-to-day analysis, primarily using LC (HPLC, UPLC, FT-IR, NIR, KF, GC, LC-MS and other analytical lab instruments), of a broad range of materials, including raw materials, in-process materials, and finished goods
Acts as liaison between functional groups, as well as segments for a wide variety of analytical aspects, including the meaning of analytical data from various sources, the quality aspects of analytical projects, and timelines for analytical projects
Proactively and cooperatively communicates with line manager to keep him/her informed of results, of obvious and subtle problems, and of likely potential problems, alternatives, and their consequences
Is capable of working independently and cooperatively to develop and validate a wide variety of analytical test methods, while routinely keeping manager informed of progress and issues
Has the ability to approach and work through simple and complex technical issues related to analysis. Proactively solves simple and complex problems through job knowledge; use of technical resources including technical literature and experts and well formulated, logical experimentation
Provides technical support and guidance for junior chemist/analyst
Where needed, provides training of analytical technicians and where needed, other analytical staff
As needed, makes recommendations to line manager regarding areas where analytical improvements should be considered or are required to improve analytical quality, effectiveness, or efficiency
Follows, understands, and complies with all SOPs and policies on GMPs and safety
Maintains a clean, safe, and organized lab area
Participates in drafting new SOPs and policies
Accurately records own data and results in a timely manner and in compliance with appropriate quality standards. As needed, reviews and provides comment on data, protocols, and reports in a timely manner
May co-author memos and scientific reports in support of Regulatory Submissions, and support quality control and manufacturing documents
Proficient in analyzing samples from various sources using analytical instrumentation, such as HPLC and GC (among others)
Some expertise in developing and validating analytical methods, alone or with supervision
Effective ability to troubleshoot analytical issues as they arise
Working knowledge of regulatory requirements for U.S. pertaining to foods, dietary supplements, and medical foods
Can manage multiple projects concurrently and set priorities in conjunction with line manager in a fast-changing, results-oriented R&D environment
Experience with the key techniques associated with the analysis of natural products is preferred, but not required
Ability to present ideas effectively and communicate well with all levels of management within a team environment on a variety of programs and projects
Experience with and understanding of CDS ChemStation (proficient in ChemStation, Empower, and other HPLC, and MS data acquisition software and proficient in troubleshooting HPLC, GC, MS hardware issues)
Proficiency in standard Microsoft programs, including Word, Excel, and PowerPoint is required
Demonstrated effective, broad technical skills, such as in: HPLC, UPLC, GC, LC-MS, KF, CE, CZE, TLC, SDS-PAGE, ELISA
M.S. in Analytical Chemistry is preferred

Analytical Scientist Resume Examples & Samples

Analytical method development, validation, and transfer activities
Formulation development work including Material characterization and physical testing
API/raw material sampling and testing, In-process and finished product testing, cleaning verification swabbing and testing
Read and interpret documents such as safety rules, operating and maintenance instructions, manuals, and standard operating procedures
Work with mathematical concepts such as mean, standard deviation and relative standard deviation
Apply concepts such as fractions, percentages, ratios and proportions to practical solutions
Identify problems, collect data, and establish facts
Knowledge of chemical concepts and theories
Familiar with a variety of laboratory equipment and data acquisition
Excellent written/oral communication skills,
Computer knowledge (excel, word)
GMP regulations
Ability to work independently as well as with others in a team environment

Packaging Analytical Scientist Resume Examples & Samples

Perform chemical analyses using chemical and physical instrumental methods in order to determine the composition of samples
Design, develop, conduct and/or review experiments (e.g., laboratory or process experiments) in order to evaluate ingredient, product or packaging safety, efficacy or claims; or evaluate new ingredients, materials, products or processes
Identify, research and evaluate new developments or trends in beverage-related industries, technologies or materials (e.g., packaging, equipment, products, processes) using various methods (e.g., scanning databases, tracking market trends, software) in order to recommend new courses of action
Conduct review of scientific or other literature in order to maintain and improve laboratory knowledge/skill, identify appropriate analytical techniques for projects/studies, or gather confidential information (e.g., information on activist groups)
Act as scientific, regulatory, technical or quality expert and consultant by responding to targeted questions from the field or other departments/business units and providing support to branches, bottlers and customers. This includes acting as a resource for general information and acting as a consultant for other technical personnel in the Company
Design, fabricate and evaluate/assess (e.g., through laboratory testing) a working package, equipment or product prototype/sample against technical requirements, fit to concept or performance specifications (e.g., functionality and operational feasibility)
Perform chemical analyses by non-instrumental methods (wet chemical methods) in order to determine the composition of samples
Write detailed & accurate reports for analyses, experiments or projects (e.g., equipment validation, evaluation of new processes)
Gather and organize information to support senior management's decision-making during a crisis situation
Prepare standards or standard curves to perform quantitative analyses
Find solutions for distressed and problem batches in order to minimize losses
Review and evaluate reported crisis (i.e., highly-urgent product related problem with immediate negative implications for the Company) and formulate a plan of action for handling the incident/issues based on area of expertise/responsibility
Basic Inorganic Chemistry: General knowledge of the composition, structure and properties of inorganic substances needed to understand inorganic ingredients (e.g., acidulants, oxygen, water, buffers) used in Company products and in research on stability of ingredients
KORE/Picasso: knowledge of KORE/Picasso requirement and database
Sensory Science/Analysis: Knowledge of sensory analysis techniques (e.g., taste, odor, appearance) and their use in understanding important flavor contributors in Company products. Includes the ability to apply the techniques to evaluate beverage quality
Basic Analytical Chemistry: Knowledge of qualitative and quantitative chemical analysis. This includes preparation, separation, detection and other techniques and applying concepts of precision and accuracy. It also includes understanding new developments in the field and their effect on our products, ingredients and packaging materials

R&D Analytical Scientist Resume Examples & Samples

Manage High-Purity Quartz QC/Analytical Laboratory in accordance with ISO 9001 procedures
Support of Manufacturing and customers through key troubleshooting investigations
Support of Technology projects by interfacing with Development Scientists/Engineers to understand the challenges of characterizing existing and new materials/products
Supervision of laboratory technician
~5 years’ experience in analytical chemistry and/or inorganic materials characterization
Solid project management skills
Demonstrated ability to build strong relationships and create an interface among Technology, Continuous Improvement, Quality, Information Technology, Commercial, Supply Chain and Manufacturing teams to maximize efficient execution of projects
Strong written and verbal communication skills
Familiarity with high temperature materials processing techniques and semiconductor industry a plus

Analytical Scientist Resume Examples & Samples

Establish, develop, and/or optimize analytical methodology to test the identity, strength, purity, potency and stability of protein products (in-process and final)
Establish, develop, and/or optimize analytical methodology to test the identity and concentration of impurities (product-related and process-related)
Establish, develop, and/or optimize analytical methodology to test the identity and purity of raw materials
Evaluate and make recommendations on new instrumentation and technology
Transfer new or improved control test procedures to customer groups
Lead troubleshooting activities for established test methods used in development and release testing. Provide analytical support in troubleshooting process and formulation problems
Conduct in-depth product failure and customer complaint investigations
Write group SOPs and provides drafts of proposed test methods to QC
Perform personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations
Must have hands on experience with chromatographic method development (GC, LC, IC) coupled to various detection methods (MS, CAD, ELSD, Fluorescence, UV)
Analysis of small molecule impurities within bioprocess matrices including sample preparation and concentration is a plus
Strong instrumental analysis background preferred with a broad range of chromatographic and spectroscopic analytical techniques such as LC-MS, ICP-MS, FTIR, SEC-MALLS, GC-MS, SE
Requires a PhD in Chemistry, Biochemistry, or Bioengineering and a minimum of 3 years relevant experience, preferably in a cGMP environment. Requires previous management experience

Senior Analytical Scientist Resume Examples & Samples

To participate in the planning and running of DOE’s, test plans, test method development brainstorming and problem solving sessions
To plan, co-ordinate and actively participate in the development and validation of test methods as required for design QA/RA. This will include internal and external testing, biomechanical and chemical analysis test methods. It will require a high standard of investigational and learning activity. It will also involve maintaining records in compliance with regulatory requirements. This will also involve providing guidance to other team members
To plan, co-ordinate and actively participate in test equipment qualification
To analyse raw materials, sub-components and finished goods associated with the R&D projects and process development. This will involve maintaining clear, precise GLP test records and will require trending, analysis and interpretation of data, and compiling of associated technical reports
To maintain appropriate laboratory supplies and equipment to ensure efficient operation of the Laboratories
Identify resource requirements for R&D projects and to support and actively participate in the development of the R&D capabilities on site
Perform training and method transfer from R&D to the QC team
To support QA/RA in investigational work or in regulatory requirements for current products
Minimum Degree in Life Sciences or related discipline
Minimum of 3 years’ experience post Degree or 2 years’ experience post Masters in test method development, validation as per the ICH guidelines, result interpretation, trouble shooting and equipment qualification
Experience in FDA regulated Pharmaceutical or Medical Device Industry with knowledge of QSR (21 CFR Part 820), GLP and MDD
Good working knowledge of MS Word/Excel/Outlook
Experience in gap analysis review of test method/equipment qualifications and/or regulatory standards would be desirable
Be a positive, energetic team player, and an advocate for product excellence and quality
Proven to be self-directed, self-motivated and able to prioritize and resolve competing priorities
Experience in leadership or guidance roles would be desirable
Experience with ISO 10993 would be desirable
Should enjoy working in a dynamic and results motivated team environment
A working knowledge of statistical techniques and analysis would be desirable
A working knowledge of planning tools would be desirable
Proven experience in the principles and practice of mechanical testing, surface science testing and GC/LC/MS

Analytical Scientist Resume Examples & Samples

Ph.D, . in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry) with 0 to 3 years of pharmaceutical industry experience, 3-5 years of analytical testing/research experience using UPLC/HPLC/GC/ICP-MS, etc
MS in Chemistry, Pharmaceutical Sciences or Life Sciences with 3-5 years of pharmaceutical experience and 5-8 years of analytical testing/research experience using UPLC/HPLC/GC/ICP-MS etc
B.S. in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Chemistry) with at least 5 years pharmaceutical industry or 8 years of analytical testing/research experience using UPLC/HPLC/GC/ICP-MS, etc
Ability to perform analytical method research and development
Strong working experience with chromatographic (e.g., HPLC or GC) and spectroscopic (e.g., UV) analysis in candidate’s research work
Understand analytical chemistry calculations such as concentrations (%, ppm, µg/mL, etc), molarity, Beer’s Law, reference standard purity on as is, anhydrous, or dry basis etc
Understand solubility, oxidation/reduction, acid/base hydrolysis, heat and photo degradation
Be able to perform basic statistical data analysis
Have good laboratory notebook documentation skills and clear/legible handwriting
Have good hands-on ability and be a quick learner
Ability to multi-task with high efficiency and work in a fast paced environment to meet deadlines
Ability to coordinate and prioritize to support manufacturing and project timelines
Ability to work well under pressure and maintain efficiency both on an individual and team basis
Advanced knowledge and demonstrated performance in regards to all lab safety process and procedures and the ability to work safely with chemicals of varying potency
General computer literacy including use of Microsoft Word, Excel, and Power Point, etc
Ability to perform analytical testing while standing for long periods of time
Accurate testing on the first attempt under pressure of production deadlines
Experience in the pharmaceutical industry preferred

Senior Analytical Scientist Resume Examples & Samples

Provide expert input to projects in the analytical chemistry department
Help the department meet turnaround time expectations by performing protocol and final report generation for specialized analytical tests, performing research in support of quote requests and new test offerings, and developing and implementing design of experiments in method troubleshooting
Oversee implementation of new laboratory equipment
Perform verifications of existing equipment

Senior QC Analytical Scientist Resume Examples & Samples

PhD or Master’s degree preferred
Quality Control experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment
Solid understanding of cGMP requirements, ISO, ICH requirements and quality systems
Demonstrated experience in QC innovation and analytical methods and validation tests development
Demonstrated experience with technology transfer methods experience
Strong team-oriented, interpersonal skills and collaborative work style
Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
Demonstrated project leadership experience

Analytical Scientist Level Resume Examples & Samples

Perform Wet Chemistry and Liquid Chromatographic testing for Injection Products under Development phase. With most emphasis on HPLC testing
Carryout wet chemistry and liquid chromatographic Analytical Method Comparisons, Analytical Method Verifications, Analytical Method Transfers and Analytical Method Development and Validation as requested
Assist when necessary in wet chemistry and liquid chromatographic analytical formulation activities of in-house newly developed formulations
Ensure that work is carried out safely and in compliance with the organization’s quality system. Ensure that quality documentation is generated and updated to reflect current best practice and that this is done in a timely manner
Take a more senior analytical role within new projects, quite often the analytical lead position, and drive towards timely and successful completion of these projects while harnessing good communication within the team and with other departments within the company
Under general supervision, the individual independently solves problems and develops solutions in more unusual situations
Schedule experiments in the lab and provides guidance to individuals in more junior positions
As a more senior analyst in R&D seek to continuously improve the way we work in R&D Analytical
Minimum of a Bachelor’s degree in a science related discipline (Preferably Chemistry or Biotechnology) with 4-6 years pharmaceutical analytical laboratory experience. However, a combination of experience and/or education will be taken into consideration
Must possess knowledge of analytical operating systems and techniques (especially HPLC) within a highly regulated pharmaceutical laboratory
Be able to work as a flexible analytical lead member of a project team, Quality Orientated, Tight Deadline Awareness, Housekeeping Aware

Analytical Scientist Resume Examples & Samples

Independently executes analytical method development and validation experiments appropriate to phase and in line with QbD approaches, based on protocols
Performs analytical work in accordance with stability protocols, and batch analysis requirements as appropriate
Recognizes the need for and begins to design modifications in protocols
Identifies and troubleshoots any problems in the execution of experimental processes; interprets results and communicates them to his/her supervisor
Demonstrates ability to perform complex data management with supervision
Proactively seeks input from other scientists to solve problems
Performs routine data management tasks including recording results effectively in a laboratory notebook or computer independently (e.g., tabulating and graphing results)
Begins to proactively incorporate new technology or techniques into practice with minimal supervision
Maintains cleanliness in own work area and in communal work areas
Anticipates/recognizes potential problems with equipment and/or supplies, and initiates action to solve or prevent problems
Operates a range of laboratory equipment independently
Works to GMP
Demonstrates timely & reliable recording of laboratory data in eE and other suitable systems in accordance with company policy and legal requirements
Consults with supervisor when difficulties arise that cannot be readily resolved
Prepares brief oral or written summaries of results with interpretation for project work
With mentoring, prepares and communicates conclusions and recommendations for next steps to relevant members of own team or Matrix Teams
Writes specific technical sections of internal and external reports with limited supervision
Follows safe Laboratory Practices
Is fully aware of safety requirements for his/her laboratory/working environment
Attends regular safety training
Maintains accurate and complete safety records consistent with company policy and legal requirements
Recognizes potential safety problems and takes action to rectify them
Perform appropriate Quality Control activities, including-
Performing analytical testing to support release or rejection of starting materials, intermediates and active pharmaceutical ingredients, intermediate, bulk and finished drug products by Quality Assurance
Developing and proposing stability protocols
Developing and proposing specifications, sampling instructions, test methods and other Quality Control procedures
Monitoring any contract analytical testing
Checking the maintenance of premises and equipment
Proposing validation protocols and performing appropriate validation of analytical methods
Possessing a degree in an appropriate discipline
Demonstrates technical expertise and working familiarity with a number of analytical techniques, and laboratory procedures
Possesses in-depth knowledge of how to analyze and interpret experimental data
Has thorough knowledge of GMP requirements, SOP’s and policies
Developing understanding of regulatory requirements
Understands the principles of Analytical Quality by Design as appropriate
Has thorough operational knowledge of laboratory equipment

GMP Analytical Scientist Resume Examples & Samples

Develop and implement robust and reliable analytical assays for the characterization of vaccine quality attributes using a range of potential analytical platforms
Work closely with the upstream and downstream processing teams to provide key analytical information regarding the quality of the potential vaccine product
Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making
Assist in the development of new methodologies in biophysical and antigenicity testing of vaccine products to advance analytical capabilities
Operate in a GMP regulated environment, follow departmental SOPs and Regulatory guidelines

Analytical Scientist Biopharmaceutical Development Process Analytical Technology & Automation Resume Examples & Samples

Develop automated purification and liquid handling platforms for biophysical characterization of biopharmaceutical process and formulation samples
Apply analytical thinking and assays to progress biotherapeutics for early and late stage products using the following techniques: HPLC/UHPLC, iCE, CE and spectrometry for analysis and characterization of monoclonal antibodies
Provide technical direction to assistant scientists
Design and conduct experiments and mine data from complex data sets of biological readouts to gain new insights
Develop and/or adopt new analytical technology, as appropriate, to advance programs
Document and communicate results in laboratory notebooks and study reports
Collaborate with other scientists in a variety of technical disciplines including Process Development, Formulation, Research, Clinical, Quality Control and Manufacturing
BS or MS in Analytical Chemistry, Biochemistry, or a related discipline with at least 4-8 years hands-on industry experience in protein characterization and methods development
Experience with automated high throughput sample preparation and analytical assays
Biopharmaceutical development experience
Demonstrated strong track record of independent critical thinking
Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment
Extensive experience with physicochemical analytical techniques, with application to new biopharmaceutical development, support of biological process development, development of process analytical technology (PAT)

Temporary Analytical Scientist Resume Examples & Samples

Contribute to the design of new particles for chromatographic applications by undertaking comprehensive chromatographic characterization of prototypes
To maintain an up to date awareness of current practices in LC and LC/MS techniques
Operate within the established NPDI framework within the business group
Provide critical and timely feedback to the R&D team
Maintain detailed records of all work carried out in lab books which are maintained as the intellectual property of the Company and as required report out in a clear, timely and informative manner
Routinely report out both verbally and written documents as required
Work within project timescales
Work effectively with team members and members of other departments on multi-functional projects
Ensure that the technical processes are thoroughly documented and operated in accordance with ISO9001
Know and fully understand the purpose of operational practices, Health &
Requires a Bachelor's, Laurea, or equivalent degree in Chemistry, Analytical Chemistry, or closely related discipline and proven related experience
Knowledge of principles, concepts, practices and standards in liquid chromatography is required
Ability to analyze moderately complex data sets and apply professional judgment to resolve a variety of problems is desired
Ability to track and analyze data using statistical functions is desired
Ability to interpret factual information and to solve problems through research of multiple alternatives and experimental design is desired
Ability to plan and execute experiments in support of research and development activities is required
Requirement to be accurate, analytical, fast learner, collaborative, team worker
Knowledge of products and fundamental understanding of how customers use these products is desired
Technical communication requirements: ability to prepare reports, protocols; ability to verbally present to small groups
Record keeping requirements: to maintain detailed records of all work carried out which may be maintained as the intellectual property of the company
Ability to build relationships and collaborate with others; strong orientation towards team work are required

Analytical Scientist Resume Examples & Samples

Demonstrated ability to develop methods, analyze, interpret date and provide compete/thorough presentations/reports
Experience with engineering polymers or plastics
Ability to pro-actively design methods to meet customer needs
Effective communication - both verbal and written
Strong understanding and commitment to safe lab practice and chemical handling
Ability to organize, keep detailed documentation and records, and achieve timely, accurate results
Ability to make minor repairs to lab equipment
Ability work independently with minimal supervisionand be part of team
Must strive for continuous improvement
Must be energetic, self motivated and flexible to help where needed in the labs
Hands on capability and interpretation skills in analytical instruments, spectroscopy such as NMR is a plus
Polymeric spectroscopy analysis -polymer backbone structure, additive package analsyis
Knowledge of polymer structure-processing-performance relationship
Knoweldge on diverse analytical techniques-NMR, FTIR, GPC, TGA, DSC, DMA, TMA, SEM, Optical Micrscope, GC, LC, MS, IV
Fluency with MS Word, Powerpoint, Excel and statistical software
Experience with DOE's, method validation (R&R) demonstration
Excellent technical writing and presentation skills
Experience in mentoring technician or junior chemist

Analytical Scientist Resume Examples & Samples

Develop and manage analytical competencies to support various Research & Development programs, manufacturing divisions and technical service requests
Employ the latest analytical technology and sound analytical principles to solve major technical problems
Keep abreast of latest advances in electrochemistry and its application to chemical phenomena and material properties
Provide necessary solutions to internal partners' analytical needs
Participate on R&D projects utilizing a variety of measurement techniques. Have sufficient breadth to recognize when other technique areas may have better applicability to technical problems
Evaluate/develop new technologies and lead efforts to implement them
Coordinate and ensure completion of projects
Working knowledge of electrochemistry, solution chemistry, titrimetric procedures or chemical property testing techniques is required
Proven analytical chemistry background is essential
Experience in laboratory automation and micro-analysis desired
Background in battery or corrosion chemistry preferred
Ability to work in a team environment is necessary
Knowledge in computers, electronics, software logic, instrument troubleshooting and statistics desired
Candidate should be motivated to develop into a company expert (leader) in solving analytical problems
Should be able to lead other scientists and technicians to provide key analytical data for product and process development and to participate in multi-disciplinary product and process development teams
Should be an innovative and creative problem solver with strong scientific convictions and willing to take risks

R&D Analytical Scientist Resume Examples & Samples

Educated to degree in a relevant scientific discipline or equivalent experience in a laboratory with good understanding of basic/specific lab equipment
Practical experience in a range of physio-chemical analysis
Well organised and capable of working on multiple activities concurrently
Planning
Informing

Analytical Scientist Resume Examples & Samples

Adhere to all quality requirements of the organization and work to improve methods in the laboratory
Work in concert with organic lab to assure timely and accurate results to customers
Act as the technical leader for HPLC and LC-MS analyses
Perform method development for new HPLC and LC-MS samples
Ph.D. in chemistry, material science or equivalent discipline
5+ years of experience with HPLC, LC-MS, FTIR and UV-Vis analytical instruments post Ph.D. degree
Considerable experience and knowledge in preparation and analysis of samples via HPLC, LC-MS
Considerable experience discussing results with customers

Analytical Scientist Resume Examples & Samples

Demonstrated experience with one of the following: HPLC-Based Methods; Gel-Based Methods; CE-Based Methods; Cell-Based Assays; Compendial Assays
Proficiency in diverse analytical techniques is required along with basic biochemistry laboratory techniques
Bachelor’s degree in science or other related degree concentration
Minimum 1 year analytical experience
Large molecule experience

Analytical Scientist Resume Examples & Samples

Perform routine chromatographic and electrophoretic separations of various large molecule (protein) samples by following written analytical procedures and utilizing existing experimental templates under the direction of a senior scientist
Support stress study sample generation
Operate and maintain common laboratory instrumentation
Maintain stocks of critical laboratory supplies and chemicals/reagents
Ability to foster team productivity and cohesiveness in a complex, matrix environment
Previous experience with one or more of the following techniques: chromatography (Size Exclusion Chromatography, Ion Exchange, reverse phase, hydrophobic interaction), electrophoresis (capillary, microfluidic, Isoelectric Focusing), UV Spectroscopy, sample preparation and handling (dialysis, desalting)
Previous experience with processing chromatographic data (Waters Empower CDS experience would be a plus)
Bachelor's degree in biology, chemistry, or other related degree concentration,

Analytical Scientist Resume Examples & Samples

Demonstrate commitment to EH&S through actively participating in the JM safety culture
Interpret experimental data and highlight any interesting or unexpected results
Contribute to the design of experimental procedures and exercise technical judgement in the execution of these
Report experiments accurately and promptly. Keep laboratory notebooks up to date in accordance with the company’s quality procedures. Write high quality reports for submission to customers
Communicate results at internal project meetings and externally to customers, under minimal supervision
Maintain and promote a high standard or scientific work either individually or as part of a team
Assist with Business Development activities when required
Consistently monitoring analytical techniques for process improvement ideas and new techniques and implementing any actions as a result of this

Analytical Scientist Level Resume Examples & Samples

Perform Wet Chemistry and Liquid Chromatographic testing of stability samples as required and trending of data in a timely manner
To ensure that work is carried out in compliance with the organization’s quality system and fully aligned with current regulatory requirements. Ensure that quality documentation is generated and updated to reflect current best practice in a timely manner
To take ownership and ensure all personally assigned systems and procedures are carried out and controlled in line with internal organization’s policies
Minimum of a Bachelor’s degree in a science related discipline (Preferably Chemistry or Biotechnology) with 2-4 years pharmaceutical analytical laboratory experience
A strong knowledge of modern analytical techniques and strong technical background is required
Must possess excellent verbal and written communication, organizational skills and computer skills including Excel, Word
Be able to work as a flexible analytical member of a stability team, Quality Orientated, Tight Deadline Awareness, Housekeeping Aware. Energy to achieve stretch goals. Track record of delivering of results and systems improvements

Technical Operations Analytical Scientist Resume Examples & Samples

Technical transfer and validation of analytical methods across a range of techniques (including HPLC, GC)
Lead all analytical related issues arising from R&D product transfers
Provide analytical support in troubleshooting and investigations of commercial processes
Responsible for the timely completion of analytical testing as required
Assist in identification and procurement of advanced analytical equipment
Contribute innovative analytical ideas to support the team
A Degree in relevant Scientific Discipline. While not a requirement, a Masters or Ph.D. is desirable
A firm grounding in principles of analytical chemistry is required
Irrespective of years of experience, a proven track record in taking ownership of analytical problems and developing robust solutions is a fundamental requirement
Experience operating to cGMP standards utilizing laboratory equipment
Expert in HPLC, GC,
Working knowledge of physical characterization techniques such as PSD analysis and XRD is desirable
LCMS and GCMS experience a distinct advantage
Familiar with method validation and remediation, relevant experience preferred

R&D Analytical Scientist Resume Examples & Samples

Provide analytical support to formulation group in order to finalize the formulation composition and components for new products
Perform Out of Specification (OOS) and Out of Trend (OOT) investigations
Responsible for Chemistry, Manufacturing and Controls (CMC) documentation required for NDA/ANDA submissions
Provide technical support to QC in trouble‐shooting on existing analytical methods
Perform Identification studies for unknowns in drug products using Raman, LC/MS, GC/MS, Raman etc
Additional responsibilities can also be assigned to support business needs
Must be knowledgeable or have hands on experience in a broad range of instrumentation including UPLC, HPLC, LCMS, GC, GCMS, Dissolution, Diffusion, Particle size, Raman, ICP‐MS, IR, UV and Nasal In‐vitro characterization techniques
Incumbent will be hired at a level based on years of relevant experience

Analytical Scientist Resume Examples & Samples

Conducting wet-chemistry and instrumental analytical chemistry analysis on in-process, final batch concentrate (FBC), monovalent bulk concentrate (MBC) sample types
Preparing analytical standards and reagents
Operating and maintaining laboratory equipment and instruments
Calculating results using Excel spreadsheets and/or instrumental software
Documenting results in electronic laboratory notebooks and reviewing notebooks of peers
Supporting senior analytical chemists on various projects as assigned
Working on second shift may be required periodically
Experience working with proteins or carbohydrates
Excellent oral and written communication skills as well as strong computer skills
Incumbent must be organized, self-motivated, and capable of working independently or in a collaborative environment
B.S. in Chemistry, Biochemistry, or equivalent, with an emphasis in analytical chemistry
Miniumum 2 years’ experience working in a laboratory environment (school or work setting is acceptable)

Senior Analytical Scientist Resume Examples & Samples

Good communication skills on technical area, major interface between functional departments and external labs
Fluent in use of computer programs in a lab setting, e g., PowerPoint, Excel, etc
Can act autonomously
Is challenging & proactive
Is pragmatic
Good communicator, coach / influencer
MS or PHD. in Chemistry, Biochemistry, or Food Science (emphasis in analysis) required
Min 5 years experiences in nutritional and food safety analysis
Breadth of experience with modern analytical methods of analysis, e.g.,LCMS,GCMS,ICS
Familiar with China official GB method for infant formula
Understanding of quality and Environment/Health/Safety standards and guideline
Good understanding of business processes in a global organization

Device Analytical Scientist Resume Examples & Samples

Responsibility for comparator product activities within Mylan Global Device Development, including building and maintenance of the physical and electronic library and comparator testing
Performs mechanical and functional testing on medical devices and combination products using standard and bespoke techniques developed to meet requirements of device testing strategy
Develop Design Verification test plans in line with ISO 11608 and ISO 11040 and other relevant regulatory guidelines. Participate in design reviews throughout the device product lifecycle by identifying and addressing any analytical gaps and providing technical expertise to the project lead. Ensure all technical issues encountered are discussed with the relevant SMEs within the design and development group
Review and interpretation of analytical data in line with study and protocol objectives. Compilation of technical reports to support design and development lifecycle
Represent the device and product performance group on cross functional teams both internally within GDD to support design control on a range of device programs
Work with external laboratories to ensure study protocols are executed in line with GDD requirements including quality and regulatory requirements
Performing method validation and verification activities to support product testing
Performing device investigations and participate in GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™. Troubleshoot instrumentation and investigate aberrant sample results
Maintaining a high standard of GMP in line with the GDD QMS ensuring audit readiness at all times
Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications for this position
Degree in Science/Engineering in addition to relevant work experience in the medical device or pharmaceutical industry
Previous experience of testing and working with medical devices and/or combination products i.e. Pre-filled Syringes or pen injectors is desirable
Previous experience in laboratory equipment qualification and analytical method verification and validation is desirable
Understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage
Highly driven and motivated person who has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks
Some travel will be required as part of this role

Quality Control & Analytical Scientist Resume Examples & Samples

Effectively manages contract laboratories with regards to quantitative and qualitative analytical testing of developmental, clinical, and commercial pharmaceutical and related products (including raw materials, in-process materials, and finished products) and reporting of results
Reviews, interprets, and evaluates analytical data, including raw data, of developmental, clinical, and commercial pharmaceutical and related products for accuracy and compliance within Otsuka and GxP requirements
Monitors stability studies of developmental, clinical, and commercial pharmaceutical and related products tested by contract laboratories
Reviews, enters, and maintains stability data for developmental, clinical, and commercial pharmaceutical and related products
Transfers analytical methods between Otsuka Japan, contract laboratories in the US, and other international affiliates
Prepares and maintains QC documentation, including protocols, reports, and test methods
Audits external analytical laboratories as subject matter expert
Procures reference materials for contract analytical laboratories
Writes/reviews CMC section of PMA, NDA and IND assuring completeness and accuracy
Maintains and updates department documents required for regulatory compliance
Assures testing requirements adherence to latest regulatory standards
Serve as a scientific liaison on selected development projects for quality control matters
Lead technical investigations
Lead the selection of external labs
Manage vendor contracts
Bachelors degree in chemistry or related science + 10 years’ work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materials
Experience with MS Office, especially MS Excel
Experience with oral solid dosage forms - tablets or capsules,
Develop technical solutions to complex problems and apply expertise to find solutions
Experience in data review
Experience in LIMS user role
Must exhibit excellent oral and written communication skills and may be required to revise or create SOP’s
Good planning and coordination skills resulting in meeting tight timelines as required
Sound judgment, decision-making skills, negotiation skills, and good organizational skills
Must have excellent interpersonal skills and must have demonstrated ability to work effectively in a multifunctional team environment (within Otsuka and externally with vendors) and is recognized as the subject matter expert for their QC projects
Possess effective project management skills that will require working with different functional groups at the same time
Develop project plans and corresponding project management tools to support the execution of all projects
Develop and manage project budgets appropriately
Develop & maintain good working/business relationships with internal & external customers

Lead Research Analytical Scientist Resume Examples & Samples

Knowledge of method development for both high-performance liquid chromatography (HPLC) and gas chromatography (GC) separations &/or mass spectrometry (MS) methods for new R&D pipeline projects and M&E problem solving projects
Development of both measurement and quantification methods through analytical methods (strong focus on either HPLC/GC &/or MS)
Participation in process development teams for the advanced of new R&D molecules in the pipeline as well as problem solving M&E projects. I.e. co-development of manufacturing processes with research chemists & chemical engineers to meet business needs and timelines
Breadth of knowledge in Karl Fisher titrations, microscopy, optical spectroscopy, advanced math modeling, would be desired, but not required
Function as a scientist within all teams following the use of the Scientific Method
Knowledge of reproducibility and repeatability theory for analytical methods
Support of sample campaign strategies (internal/external) as needed
Support of registration preparation activities as needed
Safe running of all operations for technology development, demonstration and data generation
Understand hazard evaluation and risk mitigation techniques for existing & new operations
Complete identified and agreed upon Project and team goals within specified timelines
Communicate and document results in timely fashion
Ph. D. in Analytical Chemistry, Organic Chemistry, Medicinal Chemistry, or related science / engineering degree
A minimum of 5 years of applied analytical experience
Technical Competence: Must be able to develop measurement & quantitation procedures through use of analytical methods. Required to have expertise in either HPLC/GC separations or MS structure elucidations as well as to generate and analyze data to independently help solve problems
Innovation: The objective of the job is to develop new or improved processes. The individual must be able to develop new separation methods to help problem-solve process development issues as well as by creatively applying exiting technology
Interpersonal Effectiveness: All projects are conducted in a team-based environment. Success is achieved through the effective leveraging of cross-functional resources. The individual must interact well with others and be able to build and sustain effective relationships
Initiative: The person must be able to work independently to achieve results. Assistance will be provided in defining and prioritizing goals; however, the individual must show initiative in planning and working to meet the defined objectives

Associate Analytical Scientist Resume Examples & Samples

Contribute to the quality control aspects of product development within GSK and with collaborators and third parties
Work with Quality control and Validation team to validate equipment and IT systems
Author / Review analytical method, Equipment and laboratory systems ensuring alignment with GSK standards
Support a technology transfer team to ensure successful transfer and ongoing performance of analytical methods
Collate and analyse analytical data to support process control and product characterization, release and stability
Understanding of the regulatory requirements for cell and gene therapy products
Ensure that any analytical non-conformance or OOS are highlighted to management and investigated
Ensure data integrity is maintained for all work performed
Contribute in delivery of relevant sections of regulatory filings and responses to regulatory questions
Quality control of gene therapy products within GSK or at third parties
Ensure analytical methods are fit for purpose through method qualification and validation activities
Participate in equipment and IT systems validation activities
Participate in the investigation or review of change controls, quality deviations and out of specification results
Compliance with regulations, guidelines and best practice
Manage data in appropriate systems to ensure compliance and data integrity
Provide data for regulatory submissions

Analytical Scientist Resume Examples & Samples

Leading ARQ-projects (from scope definition and planning to project execution and reporting)
Exploring and inventing new ARQ-techniques in close collaboration with other departments (R&D, plant, maintenance)
Instructing and coaching of ARQ Technicians to execute measurements
Reporting results to peers, management and R&D stakeholders
Process and evaluate (large sets of) test data
Method development and improvement
Building internal and external networks in your subject area

Temporary Analytical Scientist Resume Examples & Samples

Perform a range of assigned research experiments as directed by the Project Leader/ Team Leader Analytical Services under minimal supervision
Contribute to problem solving sessions, seminars and other scientific discussions
Efficiently manage projects when requested by the Head of Solid Form Services/ Analytical Services Team Leader
Being responsible for, and troubleshooting & maintaining Analytical equipment

Analytical Scientist Resume Examples & Samples

Develop and Validate new analytical methods
Design and execute method transfer protocols
Perform laboratory testing (qualitative and quantitative chemical and physical analysis of raw materials, finished products and/or stability samples).Review laboratory testing results
Generate, write and revise SOPs, test methods, validation protocols and validation reports
Mentor chemists/analysts in the proper execution, including interpretation of validation parameters
Provide technical support to the analytical methods used for marketed products by QC lab and products in development phase
Achieve and maintain high standards with meticulous attention to detail
Independently perform investigations, address Out of Specifications (OOS), resolve deviations and implement CAPA
Troubleshoot different analytical instruments
Lead method development projects
Serve as technical lead for specific area of expertise
Interpret test results and compare with determined standards and limits. Interpret and compare data to historical records and verifies trending
Take active role to ensure the laboratory is in compliance with cGMP and GDP
Assist in audit and compliance program to meet ISO17025 laboratory accreditation requirements (including statistical analysis of data)
Assist in drafting publication or position papers
Solid knowledge of cGMP and GDP
Well versed with various data acquisition/processing software and other laboratory controls
Highly proficient with lab instrumentation and test methods (i.e. FTIR, HPLC, ICG, GC, UV-Vis, Nitrogen Analyzer, NIR and NMR)
Strong analytical and problem solving ability
Strong trouble shooting ability for analytical instruments
Good verbal and written communication skills (technical writing and presentation)
Ability to communicate and work effectively in a team-based environment
Ability to manage and handle multiple projects simultaneously
7 years’ experience in analytical field for tests and method validation or method transfer
3+ years’ experience working in a cGMP environment
Extensive technical experience in analysis of dietary supplements, food and personal care products
Solid knowledge in method development
Proficient in NMR
Solid knowledge in ISO17025 Lab Management
Master of Science in Chemistry, Biochemistry or related scientific fields

R&D Analytical Scientist Resume Examples & Samples

Perform wet chemistry and liquid chromatographic testing of the stability samples as required
Develop familiarity with basic laboratory equipment (operation, raw data processing, and calibration)
Take ownership and ensure all personally assigned systems and procedures are carried out and controlled in line with internal organization’s policies
Ensure the laboratory area is always maintained in a clean condition and supplies of consumables are in constant stock
Minimum of a Bachelor’s degree in a science related discipline (Preferably Chemistry or Biotechnology) with 0-2 years pharmaceutical analytical laboratory experience
Must possess excellent verbal and written communication, organizational skills and computer skills including Excel, Word and lotus notes

Analytical Scientist Resume Examples & Samples

Perform testing of samples for biopharmaceutical clients utilizing EIA, DNA by qPCR, HPLC (size exclusion (SEC), reverse phase, normal phase and HIC), spectrophotometry and capillary electrophoresis (cIEF and cSDS) and SDS-PAGE
Documentation of sample results in electronic notebooks
Peer review of analytical data
At least three years relevant experience

Analytical Scientist Stability Resume Examples & Samples

Analysing VMS and OTC samples (using current methods and equipment) to ensure efficiency and accuracy within agreed timelines, primarily HPLC (Waters & Schmadzu), ICP and GC
Drawing up analytical and stability protocols to ensure valid and correct testing of samples and associated Reports
Scheduling/Co-ordinating work for the Team (on a rotational basis) to help spread the workload and ensure adequate planning
Completing Investigations and OOS Reports if required
Maintaining safety in the Laboratory and a safe work environment
Performing instrument calibrations as rostered
Contributing to productive teams working to achieve the agreed results within the Laboratory and with customers
Maintaining, improving and applying expertise and knowledge
Contributing to the integration of analytical skills/knowledge to benefit the output of the Laboratory
Bachelor of Science or Chemistry or related discipline coupled with HPLC/ICP/GC experience in a Pharmaceutical Laboratory, ideally Complementary Medicine and OTC products
Proficient understanding of GMP and GLP functions of a Laboratory
Demonstrated exceptional Technical Protocol and Report Writing skills
Excellent verbal and written skills, with the ability to interact across all departments and with all levels of the business

Analytical Scientist Resume Examples & Samples

Working knowledge of antibody purification and characterization
Excellent interpersonal, written and oral communication skills and attention to detail
The employee must be able to work independently, have excellent documentation skills, be accountable for presenting data interpretations, and directly support critical project milestones
BS/BA in microbiology/biology/biochemistry/veterinary science or related discipline with a minimum of 2 years of demonstrated work experience. The employee should have demonstrated experience in ELISA development and cell culture
MS in microbiology/biochemistry/veterinary science and 2 years of experience in analytical development, preferably in an industrial research setting. A thorough understanding of vaccinology, proven ability to develop ELISA assays, outstanding problem solving and excellent experimental design skills are highly desirable

Analytical Scientist Resume Examples & Samples

Managing the login and distribution of samples for the Analytical Services team
Materials compatibility testing on new and existing products
Must be safety-focused with chemical handling and storage
Strong organization, communication, documentation and interpersonal skills
Able to interpret data and report to customers
Troubleshooting, maintaining, and calibrating analytical instrumentation
Able to prioritize and work across various support areas for timely project completion
Ability to work in a team environment and independently with minor supervision
Associate's Degree or equivalent with 3+ years’ experience or Bachelor's Degree with 2+ years’ experience in a scientific discipline
Good analytical skills and multi-tasking skills with keen attention to detail
Working knowledge of laboratory instrumentations (Densitometer, Viscometer, Flash Point, Pour Point, and Vapor Pressure)
Computer proficiency (Outlook, Word, Excel, PowerPoint)
Must be able to lift 25 Ibs
2-4 years of industrial/chemical experience as well as knowledge of working with hazardous chemicals
Working knowledge of wet chemistry techniques (ex. Karl Fischer Titration, pH)
LIMS experience a plus

Senior Analytical Scientist Resume Examples & Samples

50% Utilize scientific expertise to independently design and conduct experimental plans, evaluate and interpret data, archive and communicate information. Develop hypotheses that can be used to test complex issues related to food, feed, biological systems and manufacturing processes and products. Develop, validate and execute analytical methods, including new-to-Cargill and world analysis
35% Participate on, and/or may lead interactive, multi-disciplined teams to identify problems, clarify questions and determine most effective and efficient solutions. Utilize skills and knowledge of capabilities to select the most appropriate analytical tools to resolve issues and provide appropriate insight. Monitor changes in available external and internal technology and advances in scientific literature. Draw ideas and concepts from peers or unrelated projects and efforts to create solutions
10% Monitor and assess current analytical methods and author SOP’s. Troubleshoot issues with analytical equipment, as well as be involved in qualification and calibration efforts. Provide guidance and training on methods and equipment to colleagues as needed. Coach junior chemists on the team. Complies with and may take leadership on EHS and Food Safety, if applicable
5% Any other duties as assigned
Bachelor’s Degree (+ 8 years’ experience), MS (+ 5 years), or Ph.D. in Analytical Chemistry, Organic Chemistry, Natural Product Chemistry or related scientific fields
Hands-on experience in analytical method development, validation and transfer in food or related industry
Knowledge of the basic principles and industrial experience in chromatography techniques (HPLC, UPLC, GC) and multiple detection systems, including mass spectrometry (MS)
Experience with instrument troubleshooting
Ability to design and execute experiments with minimal guidance
Ability to analyze results and use this analysis to make effective decisions
Good general analytical laboratory skills
Flexible, organized, and demonstrated ability to handle changing priorities
Effective communication skills (written and verbal)
Ability to demonstrate teamwork and collaboration on cross-functional teams
Ph.D. (+ 3 years industrial experience)
Familiarity with LC-MS, LC-ELSD, and GC-MS
Experience with semi-preparative LC and natural product separation, purification and compound identification Knowledge in NMR is a plus
Experience with statistical data analysis
Ability to utilize work plans or other tools to reduce project complexities. Decisions must be made on planning, direction and implementation of the project often in ambiguous situations where all needed information is not available
Interaction with other team members to leverage capability and insure effective and efficient problem solving, able to train junior chemist
Ability to identify technical tasks to solve a business problem
Ability to understand business cost and value relationships
Ability to understand business systems and function within a business environment
Understanding of legal implications of actions and government regulations

Lead Analytical Scientist Resume Examples & Samples

Provide analytical support and problem solving in support of developing formulations within R&D
Provide analytical support for process chemistry route scoping and optimization within R&D
Develop validation-ready laboratory methods for formulated products, active ingredients, and impurities
Collaborate with a variety of people from different functions and disciplines within Dow AgroSciences (Discovery; Process Chemistry; Regulatory Sciences; Mass Spec Center of Expertise; Scale-Up; Pilot Plants; Manufacturing facilities)
Communicate and document progress of projects and timelines to diverse team members and stakeholders
Interface with Dow AgroSciences research organizations and serve on cross-functional teams
Facilitate transfer of analytical methods to manufacturing quality control laboratories
A Bachelor's degree is required
Prior experience applying high-performance liquid chromatography (HPLC) or gas chromatography (GC) techniques is required
Proficiency in utilizing scientific methodology to solve technical problems
Ability to manage a broad scope of activities including but not limited to: conducting experiments, participating effectively in a team environment, and managing multiple stakeholders
Ability to effectively interact with customers, peers, plant personnel, R&D, scale-up personnel, and industrial experts
Strong communication, troubleshooting, networking, and computer skills to extract, evaluate data, and make sound technical decisions
Ability to translate complex data into clear objectives and establish practical action plans
A degree discipline in Chemistry, Analytical, or Engineering is preferred
2 years of relevant work experience is preferred
Prior experience with LC (liquid chromatography) / MS (mass spectrometry) and GC / MS is preferred

Download Analytical Scientist Resume Sample as Image file

Related Job Titles

Scientist Resume Sample

Bioinformatics Scientist Resume Sample

Formulation Scientist Resume Sample

Qc Scientist Resume Sample

Analytical Chemist Resume Sample

Post Doctoral Scientist Resume Sample

Imaging Scientist Resume Sample

Chief Scientist Resume Sample

Expert Scientist Resume Sample

Field Application Scientist Resume Sample

Material Scientist Resume Sample

Product Scientist Resume Sample

Browse More

Analytical Scientist Resume Samples

The Guide To Resume Tailoring

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Resume Builder

15 Analytical Scientist resume templates

Read our complete resume writing guides

How to Tailor Your Resume

How to Make a Resume

How to Mention Achievements

Work Experience in Resume

50+ Skills to Put on a Resume

How and Why Put Hobbies

Top 22 Fonts for Your Resume

50 Best Resume Tips

200+ Action Words to Use

Internship Resume

Killer Resume Summary

Write a Resume Objective

What to Put on a Resume

How Long Should a Resume Be

The Best Resume Format

How to List Education

CV vs. Resume: The Difference

Include Contact Information

Resume Format PDF vs Word

How to Write a Student Resume

Senior Analytical Scientist Resume Examples & Samples

Principal Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Senior Principal Analytical Scientist Resume Examples & Samples

Senior Analytical Scientist MS&T Resume Examples & Samples

Bio Analytical Scientist Resume Examples & Samples

Senior Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Principal Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Packaging Analytical, Scientist Resume Examples & Samples

Data Analytical Scientist Resume Examples & Samples

R&D Senior Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Protein Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist, In-process Testing Resume Examples & Samples

Process Analytical Scientist, Upstream Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Senior Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Senior Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Lc-hrms Small Molecule Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Packaging Analytical Scientist Resume Examples & Samples

R&D Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Senior Analytical Scientist Resume Examples & Samples

Analytical Scientist Resume Examples & Samples

Senior Analytical Scientist Resume Examples & Samples

Senior QC Analytical Scientist Resume Examples & Samples

How to Make
a Resume

50 Best
Resume Tips

200+ Action
Words to Use

Internship
Resume