Senior Scientist, Biologics Analytical Development

Job Description

Job Summary:

• Client is seeking an experienced Senior Scientist to establish and manage biologics drug substance and drug product stability programs supporting clinical development.
• The role will provide scientific, statistical, and operational oversight of studies conducted by CMOs and contract testing laboratories; evaluate stability data and trends; author and review protocols and reports; and support shelf-life, retest period, and regulatory decisions.
• The successful candidate will serve as a stability subject matter expert and collaborate with cross-functional teams and external partners to maintain compliant, scientifically sound, and data-driven stability programs.
• This is a fully remote position.

Essential Duties & Responsibilities:

• Develop stability strategies aligned with product development objectives, manufacturing plans, clinical supply requirements, and regulatory expectations.
• Define appropriate storage conditions, testing intervals, analytical test panels, acceptance criteria, and study durations.
• Author, review and revise stability protocols, interim and final stability reports, SOPS, technical memoranda, specifications, and related controlled documents.
• Perform comprehensive review, trending, and statistical analysis of stability data to assess degradation rates, variability, lot-to-lot differences, and longitudinal trends.
• Use JMP statistical software for regression analysis, graphical evaluation, shelf-life projections, retest period assessments, and other stability-related statistical evaluations.
• Identify emerging trends, meaningful changes, OOT results, OOS results, atypical findings, and potential product-quality or clinical-supply risks.
• Support establishment and justification of drug substance retest periods and drug product shelf life or expiration dating.
• Participate in or lead stability-related investigations, deviations, CAPAs, change controls, and other applicable Quality System records.
• Evaluate temperature excursions during product storage and transportation and assess potential product impact using available stability data.

Additional Responsibilities:

• Collaborate with Quality Assurance, Regulatory Affairs, Process Development, Supply Chain, Clinical Supply, and external partners.
• Identify and implement opportunities to improve stability processes, statistical methods, documentation, and external-partner performance.
• Independently manage multiple studies, priorities, external partners, and timelines in a remote working environment.

Required Education:

• BS/BA degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology or a related scientific discipline; or
• MS/MA degree in related scientific discipline; or
• PhD in a related scientific discipline.
• An equivalent combination of education and directly relevant experience may be considered.

Required Skills & Experience:

• Approximately 11 or more years of relevant pharmaceutical or biotechnology industry experience with a BS/BA degree; or
• Approximately 9 or more years of relevant experience with an MS/MA degree; or
• Approximately 5 or more years of relevant experience with a PhD.
• Extensive experience managing pharmaceutical or biotechnology stability programs in a regulated development environment.
• Strong understanding of stability principles for biologics and/or complex therapeutic products, including degradation pathways, accelerated stability studies, shelf-life determination, and retest-period assignment.
• Strong knowledge of ICH stability guidelines, particularly ICH Q1A, Q1E, and Q5C, as well as relevant FDA, EU, and global regulatory expectations.
• Demonstrated proficiency with JMP statistical software, including regression modeling, stability trending, graphical analysis, variability assessment, and statistical evaluation supporting shelf-life and retest-period decisions.
• Ability to critically evaluate longitudinal stability data and identify OOT results, emerging trends, and potential product-quality risks.
• Experience overseeing stability activities performed by CMOs and contract testing laboratories.
• Strong understanding of cGMP requirements and pharmaceutical Quality Systems, including OOS, OOT, deviations, CAPAs, and change controls.
• Strong understanding of analytical methodologies commonly used to assess biologic drug substance and drug product stability.
• Excellent technical writing skills, including experience preparing stability protocols, reports, SOPs, technical memoranda, and regulatory documentation.
• Excellent written and verbal communication skills, with the ability to explain complex scientific and statistical findings clearly to technical and non-technical audiences.
• Ability to work independently and effectively with geographically distributed teams and external partners.

Preferred Skills & Experience:

• Experience working in an FDA-regulated environment.
• Experience supporting IND, BLA, or equivalent global regulatory submissions.
• Experience developing stability strategies for late-stage clinical development and preparation for commercialization.
• Experience evaluating temperature excursions and applying stability data to product-impact assessments.