Senior Scientist, Biologics Analytical Development (Contract Role)

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Role: Senior Scientist, Biologics Analytical Development (Contract Role)

Location: Remote

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.

Key Highlights:

• Oversee execution of stability studies at CMOs and contract testing laboratories.
• Perform statistical analysis and trending of stability data using JMP
• Support determination of drug substance and drug product shelf life/retest period according to ICH guidelines.
• Author and review stability protocols, reports, SOPs and regulatory documentation.

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

Skills :

Minimum Professional 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 Qualifications

• 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.

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

Regards,

Satya

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