Scientist, Analytical Resume Samples

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T Kuhlman

Tanya

Kuhlman

993 Raynor Village

Los Angeles

+1 (555) 679 2795

993 Raynor Village

Los Angeles

Phone

p +1 (555) 679 2795

Experience Experience

Dallas, TX

Scientist, Analytical Sciences

Dallas, TX

Bosco-Zulauf

Dallas, TX

Scientist, Analytical Sciences

Function as technical resource for analytical methods and data troubleshooting, remediation, and optimization in support of Manufacturing Process activities (e.g. process characterization, optimization, investigations, etc.). Testing and data analysis for experiments supporting group activities and support to other lines
Provide technical resource for Process Analytics methods remediation, evaluation and validation. This includes partnering with analytical development to achieve method readiness to initiate validation, write validation protocol, gather data generated by analytical development/QC labs and write the validation report
Conduct periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes to existing commercial methods
Work as part of a team to develop and qualify robust impurity assays to detect insulin, host cell proteins, residual DNA, protein A , and other process-related impurities
Perform gel electrophoresis and Western-blot analyses in support of bioprocess development and reagent characterization efforts
Work closely with the bioprocess development group to support sample testing and analyze/interpret data
Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment

Detroit, MI

Senior Scientist, Analytical

Detroit, MI

Steuber-Satterfield

Detroit, MI

Senior Scientist, Analytical

Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences
Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols
Safe handling of potent and teratogenic compounds
Disposal of hazardous waste according to environmental regulations and company/departmental procedures
Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks
Assures right-first-time execution of departmental methods and SOPs
Facilitates and supports activities and services necessary to the routine operations of the department, as assigned

present

Boston, MA

Senior Scientist, Analytical Sciences

Boston, MA

Weissnat, Breitenberg and Schimmel

present

Boston, MA

Senior Scientist, Analytical Sciences

present

Proactively develop and maintain state-of-the-art knowledge in current pharmaceutical and analytical sciences related to drug development
Provide mentorship, training and guidance to associate level staff assigned on the projects and contribute to their development
Independently design and implement analytical development activities to support all stages of drug development
Make presentations at CMC meetings, departmental meetings, Pharmaceutical Development scientific meetings, and external scientific meetings
Develop, validate, and transfer analytical methods for drug substance, drug product and excipients
Provide content and review relevant sections of regulatory submissions, and help prepare responses to CMC questions from regulatory agencies
Attend pertinent scientific conferences, workshops and technical training sessions to learn and bring in knowledge

Education Education

Bachelor’s Degree in Chemistry

The Ohio State University

Bachelor’s Degree in Chemistry

Skills Skills

Knowledge of the following
H.P.L.C. and G.C. instrumentation
IR and AA instrumentation
U.V. spectroscopy
Dissolution testing
Expertise in wet chemistry techniques such as titrations, extractions, digestions and preparations of test solutions
Experience with common pharmaceutical laboratory equipment including, but not limited to,

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Scientist, Analytical Resume Examples & Samples

Maintain and ensure performances of instruments
Conduct routine and non-routine testing
Ensure timely and accurate data
Interact with clients and define analytical needs for business
Compile, interpret, document, and report results
Organize and lead projects
Organize and prioritize workflow and task schedules
Acquire knowledge and establish capability

Scientist, Analytical Sciences Resume Examples & Samples

A minimum of a PhD in chemistry, biochemistry, pharmacology or related disciplines, with a minimum of 3 years of relevant research experience is required
Postdoc and industrial experience is preferred
Hands-on experiences of using modern LCMS and GCMS instrumentation and techniques (e.g., qTOF, Triple Quad, Ion Trap, MALDI-TOF) are required
Experience with various chemical and biological techniques (e.g., blood and tissue sample preparation and metabolomics profiling) is also required
Experience in chemical probe synthesis and metabolite labeling, protein digestion, sequencing and PTM analysis is strongly preferred
Strong data analysis and interpretation skills are required
Excellent communication skills and the ability to thrive in a team and goal driven environment are required.Chemistry

Scientist, Analytical Sciences Resume Examples & Samples

Provide technical resource for Process Analytics methods remediation, evaluation and validation. This includes partnering with analytical development to achieve method readiness to initiate validation, write validation protocol, gather data generated by analytical development/QC labs and write the validation report
Assist with method transfers within and outside of BMS
Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment
Work closely with all AS&T team members to understand their deliverables to achieve organization goals
Expertise in assays used to test and characterize biological products (e.g. HPLC, gel and capillary electrophoresis, spectrometry (absorption, MS, etc.), ELISAs, etc.)
Expertise in methods qualification and/or validation with extensive familiarity with regulatory guidelines and cGMP laboratory processes
Experience working with colleagues at remote sites
PhD, MS or BS in biological sciences, chemistry or related scientific disciplines
Bio-therapeutic development & industry experience required: PhD>0-2, MS >4 years, BS >6 years
May require supervisor duties
1603639

Senior Scientist, Analytical Resume Examples & Samples

Ability to independently develop and validate instrumental methods in support of Drug Substances and Drug products
Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences
Ability to make autonomous decisions in regards to day to day activities
Analysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and validation samples according to the assigned specifications, methods and protocols
Preparation of reagents/standards/medias needed for analysis according to established methods
Safe handling of potent and teratogenic compounds
Disposal of hazardous waste according to environmental regulations and company/departmental procedures
Tabulation and interpretation of results of analysis as recorded in notebooks, reports and logbooks
Capable of self-scheduling of work assignments
Assures right-first-time execution of departmental methods and SOPs
Facilitates and supports activities and services necessary to the routine operations of the department, as assigned
Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data
Writes and reviews analytical methods, deviations, protocols, SOPs and any other technical document
Lead all analytical method transfer activities as required by their area
Supports Material Evaluation Process for new materials
Provides project support for new product development which requires a close working relationship directly with Customers as well as suppliers
Conducts and writes laboratory investigations using the appropriate Root Cause Analysis tools
Participates in inter-departmental task teams
Interfaces with peers in other departments and management
Provides support for ordering and maintaining inventory of laboratory materials and equipments
Leads and coordinates training for new or existing personnel as assigned by laboratory management
Identifies and implements process improvements that will reduce cycle time to test and release products
Performs other miscellaneous duties as required
Minimum Bachelor’s degree from four-year college or university in any of the following disciplines: Chemistry, Biology, Microbiology, or related sciences (as applicable), with an advanced degree preferred
Minimum of 7 years relevant pharmaceutical laboratory/analytical experience
U.V. spectroscopy
IR and AA instrumentation
Knowledge of the following

Associate Scientist, Analytical Ops Resume Examples & Samples

Experience in working in a pharmaceutical quality control group under cGMP regulations including analysis using different laboratory techniques, reviewing laboratory records and data and familiarity with GMP systems (LIMS, Empower, ELN)
Experience managing outsourced analytical and quality control testing activities for clinical active pharmaceutical ingredients and clinical and commercial drug products
Familiarity reviewing approval of proposals, work orders and changes of scope
Experience in transferring projects to various contract organizations and coordinating analytical testing at contract sites
Monitors and troubleshoots key outsourced testing activities via email, teleconferences and site visits
Apply current Good Manufacturing Processes (cGMPs) and Good Laboratory Practices (GLPs) concepts daily
Review data and results of tests to ensure compliance with appropriate specifications and protocols
Assist in transferring projects to contract sites
Attend weekly meetings
Facilitate communication and relationship between Gilead’s analytical departments and contract sites
Prepare information for others to present
Process work orders and track spend activities

Scientist, Analytical Resume Examples & Samples

6 years analytical laboratory experience with B.S
4 years analytical laboratory experience with M.S
0-2 years analytical laboratory experience with Ph.D

Trainee Scientist, Analytical Sciences Resume Examples & Samples

Carry out routine tasks accurately, following strict operating procedures for tasks such as sampling, measuring, weighing and data logging
General housekeeping duties (e.g. stock taking and resourcing, administrative tasks, cleaning etc.) ensuring the laboratory environment operates effectively and efficiently
Follow strict health and safety procedures in line with individual laboratory requirements
Communicate effectively and demonstrate the ability to work independently and as part of a team
Preparing specimens and samples according to in-house methods and external literature (specific client methods, pharmacopoeias etc)
Perform laboratory tests in order to produce reliable and precise data to support both Mondelez and RSSL projects
Documentation and assessment of data to monitor and deliver results; considers implications and draws conclusions. Writes technical reports / certificates of analysis with guidance from manager

Senior Scientist, Analytical Science Resume Examples & Samples

Leads and executes chemistry projects and analyses supporting the delivery of R&D category programs for Gum & Candy. Responsible for quality/speed/cost of analytical delivery
Analytical portfolio aligned with business objectives by continuous dialogue with partners and idea generation to develop appropriate new methodologies
Ensure most efficient execution of local research needs by using local, regional and global resources (internally and externally)
Be the AP technical expert for GMAP
Guides and coaches the staff in other AP locations (Thane and Suzhou) in rapid testing, analytical process control, quality assurance and selected technical areas (e.g. chromatography or physical characterization)
Reports research findings and analytical data to category groups and defines subsequent steps with clients
Continuously develops and broadens technical skills, company business/products knowledge as well as awareness of pertinent external developments and feeds back to the RD&Q respectively analytical teams
Develops strong relationships with senior members of Research and Nutrition and regularly interfaces with other departments acting as a key technological resource to Gum and Candy RD&Q
Ensures adherence to existing quality standards, defines new quality standards, implements corrective measures when necessary. Independently solves technical irregularities of equipment
Ensures adherence to all safety relevant procedures. Identifies safety risks and set new safety standards when necessary
MSc, PhD Analytical Chemistry, Chemistry, Food Science or a similar field
At least 5 years hands-on experience with complex analytical instruments and method validation in a laboratory following a QA system
Strong understanding and experience of stakeholder management
Demonstrated success using influence to achieve outcomes
Preferred is experience in using analytical testing to support R&D in a food or pharmaceutical company

Scientist, Analytical Sciences Resume Examples & Samples

Work as part of a team to develop and qualify robust impurity assays to detect insulin, host cell proteins, residual DNA, protein A , and other process-related impurities
Work closely with the bioprocess development group to support sample testing and analyze/interpret data
Perform gel electrophoresis and Western-blot analyses in support of bioprocess development and reagent characterization efforts
Present data at internal meetings and write technical reports
PhD in molecular biology, biochemistry, cell biology or related field with an advanced level of understanding in the field of protein biochemistry
Proficient in development and execution of robust ELISAs
Experience in 1-D gel and Western-blot analysis
Great problem solving skills
Strong interpersonal and organization skills

Scientist Analytical Research & Development Resume Examples & Samples

Perform release testing for active pharmaceutical ingredients, excipients and drug products using several analytical techniques such as HPLC, UPLC, GC, Viscometer, Karl-Fisher, Microscopy, Particle size analyses etc., following USP/NF and analytical procedures
Perform routine stability testing as per established analytical procedures and specifications, evaluate data and generate reports
Participate in testing related to investigations and in compliance with GMP requirements
Participate in validation of analytical methods by executing experiments from approved protocols
Support Product Development by analyzing the samples at different stages of development and innovator samples
Update analytical procedures and specifications
Peer review of laboratory notebooks and reports
Maintain laboratory equipment
Maintain current training as per the syllabus. Adhere to cGMP, SOPs and company policies
Demonstrate proper laboratory safety and housekeeping practice
Other duties may be assigned
Experience in HPLC is a must
Experience in GC is desirable
Good Analytical and organizational skills
Strong computer skills and knowledge of commonly used software for lab equipment
Knowledge of Waters Empower is a plus
Detail oriented, able to multitask and meet deadlines in a fast paced environment
Ability to learn new techniques, follow instructions as per SOP's and established analytical procedures, and comply with company policies
Ability to work, under supervision, and keep supervisor informed of findings and issues
Requires at least 2 years of experience in pharmaceutical or related industrial environment
Understanding of new drug development process, preferably dermatologic / topical product development is a plus

Scientist, Analytical Science Resume Examples & Samples

This position contributes to project planning and may lead a small team in pursuit of set goals within a single discipline. Support the development of analytical methods
This position leads comprehensive data analysis of process statistics and prepare technical reports
This position participates in training and development opportunities in order to gain an understanding of standards of practice, process science and departmental policies
This position develops technical solutions to problems independently and proactively exchange technical information with team members within Process Science and with cross functional group for troubleshooting and ongoing supports
This position identifies, propose, and execute process and procedural changes to improve business performance, process performance, robustness, productivity and efficiency
This position assists in project planning and execution including evaluation of equipment and implementation of appropriate modifications and staff training to ensure employee safety
This position ensures schedules of process equipment used in process science labs and the equipment are maintained per preventive maintenance schedule
This position supports direct communications with external and internal customers to ensure processes and methods meet specifications and requirements
This position assists continuous improvement in innovation and technology and contributes a stronger IP position for BI. This position supports establishing state-of-the-art technologies for process development

Scientist, Analytical Sciences Resume Examples & Samples

Analytical lead for method validations and transfers
QC Analytical Team lead for new biological product(s)
Good documentation practices in a cGMP environment

Associate Scientist, Analytical Sciences Resume Examples & Samples

Assist Stability Manager to design and manage stability studies for biological products
Compile stability data into stability summary reports and incorporate into regulatory filings as needed
Oversee laboratory compliance through continuous improvement of quality systems
QC Analytical Team Lead for new biological product(s)
Routine batch release and stability testing
Writing validation protocols, reports and SOPs
Supporting lab investigations and method troubleshooting

Scientist, Analytical Sciences Resume Examples & Samples

Analytical method development and qualification
Sample testing under non-GxP working environment
Product characterization by protein conformational arrays
Writing technical reports and SOPs
Presenting at internal and external scientific forums

Scientist, Analytical Immunologist Resume Examples & Samples

Drive evaluation / development / implementation of cutting-edge and existing methods for qualification of critical reagents, data review and change control assessment
Oversee critical reagent program, which includes but not limited to selection, production, qualification, re-qualification, and inventory control strategies
Manage regulatory/quality aspects to ensure adherence to all applicable quality, corporate, safety, and regulatory requirements
Scientific review of statistical analyses, summarize and interpret analytical data in support of qualification of critical reagents, write, review and approve protocols, reports, operating procedures/instructions, regulatory correspondences, and release for use documents to other platforms for clinical testing
PhD in Immunology, Biochemistry, or analytical chemistry (or related fields)
1+ year of relevant analytical testing or QC experience in vaccine/biotech/GxP industry

Scientist Analytical & Formulation Development Resume Examples & Samples

Lead a group of research associates to perform a wide range of analytical tests on mAbs and ADCs to support mAb and ADC process development activities. Communicate results and any potential issues in a timely manner
Interface with the Process Development Group to ensure that analytical methods are fit-for-purpose and provide technical advice and critical review of experiment design and data analysis to assure the highest quality of data is developed and presented
Identify opportunities for operational efficiencies and develop effective methodologies to track the progress
Responsible for assay transfer for new analytical methods established by Analytical Development group and recommend revisions to procedures to improve efficiency
Develop analytical methods as needed, transfer and qualify methods with QCA
Recruit, train, manage, and motivate direct reports as well as consultants to efficiently and effectively deliver on goals
Work collaboratively with internal and external functional teams and ensure that corporate objectives are met
Works on unusually complex problems and provides solutions that require creativity, ingenuity and sensitivity to company strategic objectives
Supervise a group of 3-5 associates
Ph.D. in a scientific discipline (Biochemistry or Chemistry) with 2+ years of relevant experience in the pharmaceutical /biotechnology industries
Candidates should possess solid analytical development experience, strong protein analytical skills, and extensive hands-on experience with: HPLC, CE and iCIEF
Should have a good understanding of statistics and standard analytical laboratory practices
Proven supervisory and managerial skills
Must have experience establishing new analytical capabilities and/or optimizing/improving current technologies
Must be highly motivated, have excellent organizational and communication skills, and must be able to work independently and as part of a multi-disciplinary team

Scientist, Analytical Resume Examples & Samples

Interprets, verifies, and approves analytical data. Leads the development of quality products through participation and representation on group and department level project teams and mentoring junior team members. Advises on current best practices, challenges, and industry trends
Maintains and troubleshoots analytical instrumentation as needed. Performs audits on equipment periodically to verify proper calibration and use. Oversees corrections
Oversees cleanliness and organization of work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use

Scientist, Analytical Resume Examples & Samples

Conducts moderately complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods
Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing
Maintains and troubleshoots analytical instrumentation as needed
Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients
Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients
Writes SOPs and other instructional documents
Cleans and organizes work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use

Data Scientist & Analytical Consultant Resume Examples & Samples

Build relationships with government clients by understanding their business challenges and formulate business solutions using analytics
Ability to quickly understand and interpret data, how it can be applied, and its limitations in order to drive opportunities down a successful path
Develop relationships with teammates and members of the global practice in order to both learn and share
Bachelor’s Degree or equivalent work experience
Five or more years’ experience in data analytics and data science with demonstrable successes using quantitative approaches
In depth knowledge of standard algorithms such as linear regression, logistic regression, clustering, decision trees, and affinity analysis
Knowledge of, and ideally use of, a wide range of common industry platforms including Teradata, Hadoop, Spark, and Teradata Aster
Ability to apply critical thinking to develop and solve business challenges
Master’s Degree preferred

Scientist, Analytical Technology Resume Examples & Samples

Write, review, and sign off on technical protocols and reports. Review subsequent regulatory filings
Independently create innovative solutions to complex technical and compliance issues
Identify, develop and implement new analytical technologies, coordinate and track activities of cross-functional multi-site teams to meet strategic goals and timelines
Lead and support troubleshooting for complex investigations in the QC labs and manufacturing investigations with an analytical component
Prepare and present scientific findings to broad audiences at department and site meetings and at external scientific conferences
Bachelor of Science in Chemistry, Biochemistry, Biological Sciences or related field and 12 years industry experience
Masters or PhD in Chemistry, Biochemistry, Biological Sciences or related field and 1-5 years industry experience
Technical expertise in bioassays and potency testing for biologics (Fret, Alpha-Screen, proliferation assays, ELISA, cell-based assays)
Demonstrated application and knowledge of ICH guidelines on analytical method validation
Knowledge of stability indicating attributes for protein biotechnology products
Excellent laboratory technique
Excellent time management and prioritization skills

Scientist Analytical Services Resume Examples & Samples

Perform routine as well as complex analyses of raw materials, in-process, finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, and other tests according to the in-house and USP monographs/methods
Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs
Maintain the laboratories with good housekeeping practices and in compliance with cGMPs
Analyze and interpret results in written and oral format in consultation with Principle Scientist and/or Sr. manager
Perform peer notebook review, train and guide less experienced scientists, and troubleshoot problems, all with minimal supervision
Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Par Safety Practices
Number of non- exempt employees supervised: 0
BS in Chemistry or related science with 4-6 years or MS with 2-4 years of relative experience
Use of respirator, lab coat and safety glasses is required. Ability to work with potent substances using a glove-box

Scientist, Analytical Lab Resume Examples & Samples

Perform analysis using various techniques including established and experimental test methods and understand how the testing effects the end product
Experience with Mechanical Force Testers (Instron) a plus
Experience with ISO and ASTM methods preferred
Experience with Plastics and Glass compendia testing/medical devices preferred
Manage projects from protocol to final report
Develop and validate methods
Keep current with new analytical technology
Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude

Principal Scientist Analytical & Formulation Development Resume Examples & Samples

Supports leadership for setting the strategic direction for analytical development and ensures implementation to support the pipeline and meet the organizational objectives
Directs the development and qualification of cGMP methods that will be used to support the Drug Substance / Drug Product for lot release and stability testing
Coordinates method transfers and qualifications with Agensys QA, Agensys QCA, and associated Astellas laboratories
Guides the extended characterization of antibody products including reference standards, degradation profiles and stability indicating assays
Responsible for the relevant CMC sections for regulatory filings
Monitors project progress, ensures compliance with agreed timetables, and serves as a technical resource when issues arise
Leads the investigation of analytical method issues and/or product stability issues
Ensures analytical support of antibody and conjugation process development
Represents Analytical and Formulation Development (AFD) on cross-functional project teams
Ensures development of technical and scientific skills for direct reports to maintain quality of analytical activities
Collaborate with stake holders to ensure high degree of engagement and alignment between analytical groups in Research and Process Sciences
Identification of new technology opportunities and assay improvements
Direct impact on ensuring product quality
Direct impact on the regulatory filings to initiate first-in-human clinical trials
This position will report into the Director of the Analytical and Formulation Group with the Technical Operations organization
BA/BS or equivalent with typically 10+ years of experience or typically 7+ years of experience with a Masters' degree or typically 5+ years of experience with a PhD in the Biologics Sciences, Chemistry or related disciplines
Must have experience establishing new analytical capabilities and/or optimizing/improving current technologies in an established lab
Proven supervisory and managerial skills are essential
Experience in method development, qualification, and transfer of chromatographic, spectrophotometric, electrophoretic, and other relevant analytical methods for protein biotherapeutics in a biopharmaceutical environment
A high level of expertise with cGMP, and regulatory compliance in biotechnology product development is expected
Strong communication, interpersonal, and leadership skills
Excellent verbal and written skills
Possesses and maintain state-of-the-art technical skills and knowledge base in a scientific discipline or technology
An in-depth understanding of protein characterization techniques with hands-on experience of LC-MS for biologics
Proven the ability to troubleshoot complex technical and scientific problems
Must be able to perform in a fast paced multi-product environment

Associate Scientist, Analytical Sciences Resume Examples & Samples

Function as a technical resource for analytical methods and data troubleshooting, remediation, and optimization in support of Manufacturing Process activities (e.g. process characterization, optimization, investigations, etc.)
Perform testing and data analysis for experiments supporting multiple products across the organization
Conduct periodic review of method performance and work with team leaders to design and execute remediation experiments and implement changes to existing commercial methods
Work collaboratively across the organization and sites for method readiness and performance and trouble shooting in the commercial environment
Expertise in assays used to test and characterize biological products (e.g. HPLC/UPLC, gel and capillary electrophoresis, spectrometry, ELISA). Proficient in the use of data acquisition systems such as Waters Empower and Molecular Devices SoftMax Pro
Familiarity with manufacturing processes for biological products
Strong written and communication skills, experience working in a matrix organization, flexibility to succeed in a dynamic environment, ability to work effectively in team situations, and independently
MS or BS in biological sciences, chemistry or related scientific disciplines
Bio-therapeutic development and industry experience required: MS > 2 years, BS > 4 years

Senior Scientist, Analytical Sciences Resume Examples & Samples

Independently design and implement analytical development activities to support all stages of drug development
Represent department and actively participate in multiple CMC sub-teams: contribute to team strategies; provide high quality data to guide understanding and decisions; collaborate with other functional areas to solve technical problems and meet project development milestones
Develop, validate, and transfer analytical methods for drug substance, drug product and excipients
Troubleshoot and solve analytical problems to assure timely completion of projects and technical reports to meet CMC project timelines
Proactively identify potential analytical or project issues and mitigate or address appropriately
Prepare, review and approve analytical data, technical reports and analytical methods
Provide content and review relevant sections of regulatory submissions, and help prepare responses to CMC questions from regulatory agencies
Provide mentorship, training and guidance to associate level staff assigned on the projects and contribute to their development
Proactively develop and maintain state-of-the-art knowledge in current pharmaceutical and analytical sciences related to drug development
Make presentations at CMC meetings, departmental meetings, Pharmaceutical Development scientific meetings, and external scientific meetings
Publish scientific papers and give presentations at both internal and external meetings
Attend pertinent scientific conferences, workshops and technical training sessions to learn and bring in knowledge
Investigate new technology and research opportunities. Recommend new technologies to the department management and proactively introduce them to the department

Senior Scientist Analytical Immunology Resume Examples & Samples

The successful candidate will be expected to demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed
Must have strong presentation skills and a record of presenting/publishing of previous work, both internally and externally
3+ year of relevant analytical testing or QC experience in vaccine/biotech/GxP industry
Working knowledge of GxP, ICH guidelines and international regulatory requirements

Data Scientist / Analytical Developer Resume Examples & Samples

Works with our businesses to understand problem domains and gives guidance on possible solutions
Develops information extraction pipelines combining custom-built tools with open source software to transform unstructured to structured data
Providing education and mentoring to XL Catlin’s actuarial and analytical colleagues on Data Science approaches to raise awareness and adoption of these techniques
Researches technical solutions for data wrangling and provides input into data science strategy and XL Catlin’s overall use of technology
Postgraduate degree in computer science, software engineering or a related field
Proven development experience, ideally within a team and/or shared through a public repository such as Github
Experience in deploying tools, using products such as Heroku, CircleCI, Azure, AWS
Excellent communication skills with the ability to explain technical concepts in simple terms
Detail oriented, reliable with good organizational skills
Interest in visualization and story telling
Proactive and able to work with minimal supervision

Senior Scientist, Analytical R&D Resume Examples & Samples

BS + min. 7 years’ experience in the pharmaceutical analytical chemistry or related sciences, with hands-on knowledge of current analytical techniques OR
MS + min. 5 years in areas noted above or
Ph.D + min 3 years in areas noted above
Strong knowledge of the major analytical techniques: HPLC/UPLC, GC, dissolution, FT-IR, etc
Strong knowledge of FDA/ICH regulations
Ability to write analytical test method, method validation protocols and reports
Ability to complete assigned duties and tasks with minimal supervision
Ability to train junior scientists on analytical techniques
Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures
Quantity - Meets productivity standards; completes work in timely manner; strives to increase productivity; works quickly
Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics
Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things
Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans
Initiative - Volunteers readily; undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed
Dependability - Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan
Teamwork - Balances team and individual responsibilities; exhibits objectivity and open to other views; gives and welcomes feedback; contributes to positive team spirit; puts success of team above own interests; able to build morale and commitments to objectives; supports everyone's efforts to succeed
Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information
Respirator, lab coat and safety glasses required. Ability to work with potent substances using a glove-box

Senior Scientist, Analytical Resume Examples & Samples

Bachelor’s degree (Ph.D or Master's degree preferred!)
5+ years’ experience in Analytical lab
Strong self-motivation and leadership skills
Knowledge of regulatory requirements and pharmaceutical, analytical and/or manufacturing processes
Ability to prepare/present oral and written presentations

Data Scientist / Analytical Consultant Resume Examples & Samples

This position is located in our Irvine, CA office. Candidate must be willing to relocate or should currently be located in this area
Master's degree in statistics, mathematics, computer science, engineering, or the physical sciences
At least 2 years related experience such as analyzing data and/or building analytical models; in either an academic or professional setting
Good programming skills with knowledge of operating systems (e.g. Unix/Linux), scripting languages (e.g. Bash, Perl, Python) and the ability to deal with very large volumes of data
Ability to communicate with people of various technical and business backgrounds, including the ability to explain difficult technical concepts in simple terms to business users
Thorough knowledge of several supervised and unsupervised modeling techniques such as Logistic/Linear Regression, SVMs, Neural Networks / Deep-Learning Networks, Boosting/Ensemble methods, Decision Trees, Clustering, etc
Ability to think analytically, write and edit technical material, and relate statistical concepts and applications to technical and business users
Ability to travel as business requirements dictate
Ph.D. in applied statistics, mathematics, computer science, engineering, or the physical sciences
Industry experience in mathematical/statistical modeling, pattern recognition, or data mining/data analysis
Extensive experience specifying and building advanced analytic solutions for the financial services and related industries with large-scale transaction data
Extensive experience in data management, deployment and product support for advanced analytic solutions
Excellent programming skills and knowledge of SAS and scripting languages
Ability to translate model performance to financial benefit for the business by incorporating knowledge of customer business practices
Willing to relocate or currently located in the Irvine, CA area

Senior Scientist Analytical Techniques Resume Examples & Samples

You are an expert of the analytical aspects important in the production of Established Products
Plan, design and coordinate analytical activities during projects (e.g. method development, validation)
Represent the department in cross functional project teams

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