Scientist, Analytical Development Resume Samples

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J Padberg

Joy

Padberg

5119 Dibbert Extensions

Detroit

+1 (555) 839 2154

5119 Dibbert Extensions

Detroit

Phone

p +1 (555) 839 2154

Experience Experience

Dallas, TX

Scientist, Analytical Development

Dallas, TX

Thiel-Schmidt

Dallas, TX

Scientist, Analytical Development

Interfacing with key CMOs to generate PAT data during early development for key unit operations (blending, drying, etc)
Developing PAT methods (NIR, Raman, particle size) and data models to support unit manufacturing operations
Authoring and reviewing source documents for regulatory submissions
Implementation of PAT methods/models for real time in-process controls and real time release testing
Support drug substance process development including characterization of starting materials, intermediates and final API
Author high-quality documentation, including methods, protocols, and technical reports
Provide training, leadership, and supervision to junior scientific staff

Houston, TX

Associate Scientist, Analytical Development

Houston, TX

Schuster Group

Houston, TX

Associate Scientist, Analytical Development

Independently develops/optimizes analytical methods to characterize protein/antibody, including, but not limited, to RP-HPLC, SEC, cIEF, and CE
Performs lab overview for client tours and internal clients (shadowing)
Understands method qualification and executes method qualification protocols. Writes qualification reports
Writes complex procedural SOPs
Mentors or trains others, as assigned
Maintains project timelines
Troubleshoots and problem solves analytical methods and instrumentation

present

Philadelphia, PA

Principal Scientist, Analytical Development

Philadelphia, PA

Deckow, Wehner and Stoltenberg

present

Philadelphia, PA

Principal Scientist, Analytical Development

present

Manage and execute transfer of analytical methodologies from internal QC and analytical development groups to external CRO’s
Oversee and manage outsourced activities at partner CRO’s, to ensure timely generation of high quality data
Support drug product formulation and process development including characterization of the process and finished product
Perform hands on analytical assay troubleshooting
Develop, optimize and validate analytical methods
Provide leadership and supervision to scientific staff
Develop, coach and mentor others

Education Education

Master’s Degree in Protein Biochemistry

University of Oregon

Master’s Degree in Protein Biochemistry

Skills Skills

Strong statistical knowledge and capabilities
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances
Strong capabilities in experimental design and execution
Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR
Design and plan stability studies
Demonstrated ability to propose strategy and manage development, qualification, and documentation
Strong verbal and written communication skills
Ability to provide scientific guidance, leadership and training to others within the department
Ability to work independently
Strong scientific background with hands-on experience in immunoassay development

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15 Scientist, Analytical Development resume templates

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Scientist, Analytical Development Resume Examples & Samples

Advanced analytical chemistry (HPLC/UHPLC, GC, Dissolution, FTIR, UV/Vis, KF, LC/MS, etc.)
HPLC and GC method development, with emphasis on small molecules
Strong instrumental background with comfort in troubleshooting and minor maintenance
Knowledge of pharmaceutical sciences
Statistical analysis for analytical chemistry
Proficiency with computer applications
Understanding of cGMPs, ICH guidelines, and compendial requirements
Experimental design including application of QbD
Design and execution of formulation and process development experiments
Data recording, interpretation, and management
Mentoring of junior staff
Significant experience in analysis of small molecule drugs
Master’s Degree in Chemistry with 3-5 years of experience or Bachelor’s Degree in Chemistry with 6+ years of experience
Other fields of specialty in sciences are also acceptable provided sufficient chemistry coursework is completed and expertise established

Scientist, Analytical Development Resume Examples & Samples

Transfer analytical methodology to quality control and contract laboratories
Author/review filing documents/technical reports to support regulatory applications (INDs, IMPDs, and NDAs)
Provide training, leadership, and supervision to junior scientific staff
Adhere to all relevant compliance requirements
Demonstrated ability to manage the development and qualification of analytical methodologies for the characterization and understanding of pharmaceutical products (both API and DP) and processes. Experience in supporting the development of pediatric formulations is a plus
In-depth knowledge of characterization techniques, e.g., liquid /gas chromatography, dissolution (USP App I and II), and mass spectrometry with extensive laboratory experiences is a must. Experience with advanced dissolution techniques, e.g., USP App III and IV, biphasic dissolution and knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR are highly valuable
Knowledge in formulation development, drug product processing or pharmaceutical sciences is highly desirable
Working knowledge of cGMP and applicable FDA, EMA and ICH guidance and familiarity with the USP and other compendia are expected
Strong verbal and written communication skills, strong interpersonal skills and the ability to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued

Associate Scientist, Analytical Development Resume Examples & Samples

Executes all activities related to the analysis of proteins from mammalian cell culture ranging from SDS-PAGE analysis, ELISA analysis, various HPLC based methods, cIEF and product binding assays. The position requires strong documentation skills and the ability to follow SOPs
Independently develops/optimizes analytical methods to characterize protein/antibody, including, but not limited, to RP-HPLC, SEC, cIEF, and CE
Understands method qualification and executes method qualification protocols. Writes qualification reports
Troubleshoots and problem solves analytical methods and instrumentation
Works on special client projects, including client interaction as appropriate/necessary
Reviews analytical data and reports ensuring accuracy and consistency
Accurately ships samples to clients and fills out appropriate paperwork
Mentors or trains others, as assigned
Hands-on experience in developing/optimize HPLC/UPLC methods for protein/mAb analysis, including but not limited to RP-HPLC, SEC, and IEX
Experience in SDS-PAGE, Western, and ELISA and other general biochemical analyses
Familiar with biophysical methods for protein/mAb characterization, such as CD, DSC, MFI, and light scattering, is a plus
Experience writing standard operating procedures and development reports
Direct Reports: NA

Scientist, Analytical Development Resume Examples & Samples

Support drug substance and drug product impurity characterization and identification
Provide leadership, teaching and mentoring to scientific staff
Report and discuss analytical results and conclusions both orally and in writing
Review analytical data for completeness and correctness
Ensure that all facilities, equipment and personnel are and remain in compliance with cGLP / cGMP, FDA and EMA requirements, appropriate SOPs and corporate policies
LI-KM1
Familiarity with synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences is expected
Familiarity with the USP and other compendia
Strong statistical knowledge and capabilities
Skills in DOE, Lean and/or Six Sigma
Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR

Associate Scientist, Analytical Development Resume Examples & Samples

2) Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols with limited supervision
3) Knows the fundamentals of analytical methodology and is able to troubleshoot instrumentation and method performance issues of moderate complexity
4) Documents / reviews laboratory work using laboratory notebooks / worksheets that is detailed, timely and in compliance with GLP / GMP requirements
5) Contributes to the preparation of high-quality technical reports as source documents for regulatory submissions
6) Reviews data for compliance to specifications and acceptance criteria
7) Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy. Draws basic conclusions from data and results
8) Other duties as assigned by supervisor
BS/MS Chemistry (or relevant discipline)
Minimum 3 - 5 years recent cGMP / GLP pharmaceutical laboratory experience
Experience with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc
Good verbal and written communication skills, can work well in team environment to achieve results and team expectations clearly and concisely in a timely manner

Scientist, Analytical Development, Biologics Resume Examples & Samples

Support drug substance process development including characterization of starting materials, intermediates and final BDS
Write/review/approve protocols and reports
Write and/or review registrational dossiers, as required
Review and approve analytical data from development partners
Plan and execute technology transfers
Work with cross-functional groups to drive project goals to timely completion
Extensive experience with the implementation of advanced analytical methods and biophysical characterization techniques such as HPLC, CE, MS, and Spectroscopy
Experience with various bioanalytical techniques such as SDS-PAGE, CE-SDS, ELISA, Cell-based bioassays, BIAcore, cIEF, etc
Demonstrated experience with therapeutic protein characterization for inclusion in registrational filings
In-depth knowledge of cGMP, FDA and ICH guidances and industry standards for therapeutic protein development and characterization
Excellent analytical skills and hands-on experience with the aforementioned techniques
Strong verbal/written communication and interpersonal skills as a team player and be willing to work in an environment where individual initiative, accountability, and professional integrity are required
Demonstrated ability to work independently and in cross-functional, multi-discipline team environment with minimal supervision

Principal Scientist, Analytical Development Resume Examples & Samples

Support drug product formulation and process development including characterization of the process and finished product
Provide leadership and supervision to scientific staff
Develop, coach and mentor others
Represent the company in discussions with regulatory authorities
Academic background in Analytical Chemistry or an allied chemistry discipline (e.g. Physical, Organic) with demonstrated analytical capabilities
Comprehensive knowledge of chemistry with extensive expertise in measurement science
Extensive laboratory experience with and an in-depth knowledge of conventional laboratory characterization techniques such as HPLC, GC, UV, IR, mass spectrometry, and NMR is a must
Ability to provide scientific guidance, leadership and training to others within the department
Ability to manage others and a commitment to and demonstrated proficiency in employee development
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances
Advanced skills in statistics and statistical analysis of process capability

Senior Scientist, Analytical Development PCS Resume Examples & Samples

Experience with analytical HPLC methods such as RP-HPLC, SEC, and IEX
Experience with mass spectrometry sample preparation and data analysis a plus
Experience with Bruker QTof and Thermo Orbitrap a plus
Experience running epitope mapping by MS a plus
Experience with Waters UPLC, Agilent HPLCs, Empower and Chemstation
Ability to work in intense, fast paced, matrixed work environment
Strong sense of initiative and interest in learning new technologies
Good interpersonal skills essential to effectively work with colleagues

Associate Scientist, Analytical Development Resume Examples & Samples

Selects appropriate methods and techniques in performing methods development
May design new experiments to support development of drug substances and drug products or techniques to test such substances
Uses strong communication skills (both verbal and technical) and interpersonal skills to communicate objectives and results
Requires a PhD in Chemistry with research conducted in a related area
Experience with the following analytical techniques preferred: HPLC, GC, MS, ICP, LC-MS, GC-MS, NMR
Must be able to participate in highly effective teams

Research Scientist, Analytical Development Resume Examples & Samples

Independently plans and executes experiments that support development activities and project goals
Applies advanced level of understanding of project goals and methods
Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems
Works independently and determines methods and techniques on new or difficult assignments
Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors
Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects
Requires a PhD in Chemistry with a minimum of 2 years industrial or postdoctoral experience
Strong understanding of separation science principles required
Willingness to learn ICH Guidelines: Q2, Q7, Q11, M7

Research Scientist, Analytical Development Resume Examples & Samples

Responsible for directing and executing scientific research for the development of drug candidates or the research support of marketed drugs
Investigates the feasibility of applying advanced principles and techniques of related scientific specialty to products and problems
Recommends the development of state-of-the-art techniques to characterize substances, assays and tools
Provides direction to Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors
Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes
Maintains in-depth knowledge of principles and theories, applying such knowledge to the research direction that supports Company interests
Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy
Requires a PhD in Chemistry and 7+ years of relevant experience
Aptitude to make significant contributions within specialty and sustained strong performance and accomplishments that align to company goals
Thorough understanding of regulations related to method development in the pharmaceutical industry: cGMP (CFR Part 211 and ICH Q7), ICH Quality Guidelines and Multidisciplinary Guidelines, USP, EP, and JP
Excellent verbal communication skills and interpersonal skills are required
Requires ability to use common tools for effective scientific communication within the company
Maintains full working knowledge of state-of-the art principles and theories, applying such knowledge to the research direction that supports Company interests
Process Development: 7 years

Scientist, Analytical Development Resume Examples & Samples

Work hands-on in the laboratory to develop, optimize, qualify, transfer, and validate analytical test methods for both drug substance and drug product, from preclinical nomination through late-phase clinical development
Conduct in-house stability studies and interpret stability data to justify material use periods
Build kinetic stability models for formulation screening and packaging selection
Author high-quality documentation, including methods, protocols, and technical reports
Coordinate and oversee method validation and testing at contract laboratories and manufacturers
Collaborate with Chemical Development and Formulation Development scientists on CMC teams to meet program goals
Act as an exemplary and data-driven scientist with critical thinking and innovative problem solving skills in a fast‑paced, can-do environment

Scientist, Analytical Development Resume Examples & Samples

Write, revise, and maintain SOPs to manage critical reagents and reference materials
Work with crossfunctional teams to establish the demand of critical reagents and reference materials for supporting of clinical trail materials testing
Generate qualification protocols, qualification reports, and issue certificate of characterization for critical reagents and reference materials production/qualification as necessary
Maintain inventories of antisera, qualified antibodies, and reference materials
Work directly with CRO and CMO to generate critical reagents
Execute and manage stability studies for critical reagents and reference materials as approprirate
Maintain/manage CTM stability data including protocol and report writing
MS with a minimum of 4 years or BS with a minimum of 6 years experience in vaccine or biologics assay development
Strong scientific background with hands-on experience in immunoassay development
Extensive hands-on experience with writing SOPs, protocols, and technical reports
Experience with critical reagents generation and qualification
Demonstrated ability to propose strategy and manage development, qualification, and documentation
Prior experience working in a biopharmaceutical assay development environment and knowledgeable with GMPs and FDA/ICH guidelines is preferred
The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP testing environment

Scientist, Analytical Development Resume Examples & Samples

Developing PAT methods (NIR, Raman, particle size) and data models to support unit manufacturing operations
Interfacing with key CMOs to generate PAT data during early development for key unit operations (blending, drying, etc)
Transfer and validation of methods/models for unit operations to allow for application to continuous manufacturing
Implementation of PAT methods/models for real time in-process controls and real time release testing
Present to cross functional teams and effectively communicate critical issues and solutions
Authoring and reviewing source documents for regulatory submissions

Scientist, Analytical Development, Biologics Resume Examples & Samples

Design and implement methods for the characterization of therapeutic antibodies and ADCs
Specify, purchase, install and maintain analytical equipment for the Biologics laboratory in San Diego
Design and lead the successful execution of experiments for comparability and developability assessments
Support therapeutic antibody and ADC drug substance (DS) and drug product (DP) process development and formulation activities
Work in close collaboration with formulation and discovery scientists, DS development scientists, quality assurance (QA) and Regulatory CMC groups
Transfer of analytical methods to support Tox or GMP campaign
Participate in team efforts to advance scientific development and technologies
Prepare presentations for group and project meetings as required
Author internal procedures and reports and contribute to external publication/scientific presentations
Maintain electronic lab notebook and records in accordance with department policy
Be a hands-on presence in the laboratory
Academic background in Analytical Chemistry, Biochemistry or related discipline (e.g. Molecular Biology, Immunology) with demonstrated analytical capabilities
Must possess an in-depth knowledge of protein biologics critical quality attributes and post-translational modifications
A demonstrated record of scientific accomplishment, laboratory experimentation, publications and presentations
Extensive laboratory experience with and an in-depth knowledge of analytical method development and implementation including: HPLC (RP, SEC, IEC, NP, and HIC), capillary electrophoresis (CE), capillary isoelectric focusing (cIEF), SDS-PAGE, and glycan analysis
Must possess experience and understanding of mass spectrometric techniques particularly with developing and implementing LC-MS methods using TOF and Orbi-trap instruments for intact mass analysis, reduced and non-reduced peptide map analysis
Strong problem-solving and troubleshooting skills
Strong capabilities in experimental design and execution and data interpretation
Ability to provide scientific guidance, leadership and training to others within/outside the department
Knowledge of cGLP / cGMP, FDA, EMA and ICH guidances and industry standards for therapeutic protein development, analytics and characterization
Advanced skills in statistics and statistical analysis of data for decision making
Advanced skills in DOE
Quality by Design
Biophysical characterization techniques including spectroscopy (UV/Vis, CD, fluorescence, FTIR), calorimetery (DSC, ITC), light scattering (static and dynamic LS), analytical ultracentrifugation
Familiarity with ELISA, BIAcore, Octet

Senior Scientist, Analytical Development Resume Examples & Samples

As the analytical lead on one or more project teams, this Sr. Scientist is responsible for the development, vetting, and implementation of the comprehensive analytical control strategy to advance the asset throughout development
Serve on and lead departmental, interdepartmental and project teams
Ensure that all facilities, equipment, and personnel are and remain in compliance with applicable cGMP and regulatory requirements, appropriate SOPs and corporate policies
LI-AS1
PhD with 5+ years or MS with 10+ years of industry experience in Analytical Chemistry or an allied chemistry discipline (e.g. Physical, Organic) required with demonstrated analytical capabilities
Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences is expected
A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation
Extensive hands-on laboratory experience with and an in-depth knowledge of conventional laboratory characterization techniques such as HPLC, GC, UV, IR, mass spectrometry, and NMR is a must
Strong capabilities in experimental design and execution
Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued
Experience in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables)
Advanced skills in DOE, Lean and/or Six Sigma
Modern laboratory automation

Scientist Analytical Development Resume Examples & Samples

A fundamental understanding of protein chemistry, general protein analysis, and characterization methods
Extensive experience with quantitative analytical method development using at least one of the following techniques
Common modes of chromatographic separation such as size exclusion, reversed-phase, ion-exchange, and hydrophobic/hydrophilic interaction chromatography
Non-chromatographic protein analysis techniques such as CE-SDS, iCIEF, ELISA and other plate-based assays, carbohydrate analysis, UV-Vis spectroscopy, or mass spectrometry
Interest in implementing new methods and technologies
Ability to independently design and perform experiments, to identify problems and troubleshoot solutions, and to consistently and timely prepare accurate and complete experimental records
Excellent organizational, oral, and written communication skills, including a customer-focused attitude and ability to work in cross-functional teams
Ability and desire to work comfortably in a fast-paced team setting, collaborate with other groups, and deliver results in line with project and team objectives
Ph.D. or equivalent in biology, biochemistry, analytical chemistry, or a relevant scientific discipline, with 2 or more years of industry or relevant experience; candidates with Bachelor’s or Master’s degrees will be considered with the appropriate experience
Experience with qualification, validation, and/or transfer of analytical methods
Experience authoring technical documents
Understanding of biopharmaceutical development
Experience in a protein quality control, purification, protein analysis, core, or process development laboratory
Lab management experience
1603718

Scientist Analytical Development Resume Examples & Samples

Develops, troubleshoots and conducts stability and purity indicating HPLC methods in support of synthetic route and formulation development
Development of a broad array of control methods suitable for drug substance and drug product analysis
Maintains accurate records of experiments and results in an electronic laboratory notebook
Demonstrates the ability to present results in both oral and written reports
Demonstrates knowledge of scientific principles and understanding of applicable drug development regulations
Complies with applicable SOPs
Contributes directly to authoring INDs/CTAs
A BS, MS or PhD in Chemistry, Pharmaceutical Chemistry, or related discipline with applicable academic or industrial experience
Minimum Experience: 8+ years (Bachelors); 5+ years (Masters); 2-5 years (PhD)
Knowledge of HPLC, GC, and other analytical techniques applied to small molecule analysis are required
Self-motivated, hard-working, detail-oriented individual able to work successfully in both a team/matrix environment as well as independently
The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects is required
A basic knowledge of cGMPs is required
Knowledge of organic structure, functional groups, chemistry, and API process development is preferred

Scientist Analytical Development Resume Examples & Samples

Development of analytical control methods suitable for drug substance and drug product analysis
Design/execute stability studies for drug substance and drug product
Design phase appropriate method validation protocols to support clinical development phases
Establish drug substance and drug product specifications and retest period, storage, and shipping conditions
Maintains accurate records of experiments and demonstrates effective communication to cross functional teams on analytical issues and solutions
Author and review source documents for regulatory submissions
Knowledge of HPLC, GC, KF, Dissolution and other analytical techniques applied to small molecule analysis are required
Well-organized, self-motivated, hard-working and detail-oriented individual able to work successfully in both a team/matrix environment as well as independently

Principal Scientist, Analytical Development Resume Examples & Samples

Manage and execute transfer of analytical methodologies from internal QC and analytical development groups to external CRO’s
Oversee and manage outsourced activities at partner CRO’s, to ensure timely generation of high quality data
Resource planning and project forecasting with external CRO’s; sample testing submissions and coordination at external labs
Ensure high quality documentation generated to support regulatory filings
Perform hands on analytical assay troubleshooting
Review of data and generated protocols and reports at partner CRO’s
BS or MS with a minimum 15 years’ of industry experience or PhD with 10 years of experience, in analytical chemistry, biochemistry, biology or molecular biology, pertaining to the development of complex formulated biological or small molecule products
Demonstrable evidence of transferring established methods to internal or external partners
Ability to effectively document and communicate results
Knowledge of the regulatory environment, particularly ICH, guidelines on analytical method development and validation and application of USP and Ph. Eur. methods
Experience in early phase (PhI / PhII) drug development
Experience in project management role, leading projects and/or project teams
Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations
Must be independent and able to proactively apply knowledge in the design, execution and qualification of analytical methodologies
Experience in the characterization nucleic acid products (plasmid DNA, RNA, oligonucleotides)
Experience in late phase (PhIII) drug development
Experience is bio/pharmaceutical operations role having responsibility for budgeting, facility or resource planning, test sample testing coordination

Associate Scientist, Analytical Development Resume Examples & Samples

B.S. in Chemistry, Biochemistry or related discipline with at least 4 years of related laboratory experience OR a M.S. in Chemistry, Biochemistry or related discipline with at least 3 years of related laboratory experience is required
Experience in at least 3 of the following areas: SE-HPLC, cSDS, ELISA, HCP, LCMS and/or cIEF is required
Demonstrated experience with database and forecasting are preferred
Knowledge of cGMP regulations, basic understanding of data trending, use of electronic notebook and Empower are preferred
Technical writing experience (SOPs and Protocols) is preferred
Up to 5% domestic or international travel is required3237170611

Senior Scientist, Analytical Development Resume Examples & Samples

Advanced Analytical Chemistry (Dissolution, HPLC, GC, FTIR, UV/Vis, KF, LC/MS etc.)
Statistical analysis for Analytical Chemistry
CGMPs, ICH Guidelines and Compendial Requirements
Project planning and management
Collaborate in the design and execution of formulation and process development experiments
Supervision of two junior staff
PhD in Chemistry with 3+ years of experience or Masters Degree in Chemistry with 10+ years of experience
Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed and expertise established

Senior Scientist, Analytical Development Resume Examples & Samples

Supervise/mentor junior scientists
Support drug substance and drug product impurity/degradant characterization and identification
Represent analytical function on cross-functional and project teams
Oversee analytical activities at CROs and CMOs including method development and transfer, method validation, reference standard qualification, release testing, stability, and technical investigations
LIPOT6
1) Demonstrated ability to manage the development and qualification of analytical methodologies for the characterization and understanding of pharmaceutical products (both API and DP) and processes. Experience in supporting the development of enabling formulations and lyo/parental formulations is a plus
2) In-depth knowledge of characterization techniques, e.g., liquid /gas chromatography, dissolution (USP App I and II), and mass spectrometry with extensive laboratory experiences is a must. Experience with advanced dissolution techniques, e.g., USP App III and IV, biphasic dissolution and knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR are highly valuable
3) Knowledge in formulation development, drug substance /drug product processing or pharmaceutical sciences are highly desirable
4) Working knowledge of cGMP and applicable FDA, EMA and ICH guidance and familiarity with the USP and other compendia are expected
5) Strong problem-solving and troubleshooting skills, strong capabilities in experimental design and execution, as well ability to work independently are essential
6) Strong verbal and written communication skills, strong interpersonal skills and the ability to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued
7) Proven skills and ability to work collaboratively with both internal and external partners

Scientist Analytical Development Resume Examples & Samples

Cover all analytical aspects during the project development lifecycle
Close collaboration with co-workers, cross-functional partners from e.g. process development, manufacturing, regulatory affairs, and quality assurance
Planning and documentation of experiments/results independently, and preparation of regulatory submissions such as IND and NDA

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