Contract: Manager, CMC Stability Management and Analysis

• Review stability data for completeness, accuracy, data integrity, trend behavior, specification compliance, and consistency with expected product quality attributes. 

• Support evaluation of OOS/OOT results and atypical trends. 

• Prepare stability summaries, trend reports, shelf-life assessments, retest/expiry recommendations, and technical risk assessments to support program decision-making. 

Qualifications

• Bachelor’s or advanced degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related field. 

• 8+ years of experience in stability, QC, Analytical Development, CMC, or technical operations within the biotechnology or biopharmaceutical industry, or equivalent. 

• Demonstrated experience managing GMP stability programs for biologics, monoclonal antibodies, fusion proteins, or other large molecules; ADC experience preferred. 

• Hands-on experience with stability data review, trending, shelf-life assessment. 

• Prior experience managing external CTLs, CDMOs, CROs, or stability storage vendors supporting regulated studies. 

• Working knowledge of GMP requirements, data integrity expectations, ICH stability guidance, and regulatory expectations for biologics stability studies. 

• Contract or consultant experience in a matrixed biotech environment preferred. 

Knowledge and Skills

• In-depth understanding of biologics stability program management, including drug substance and drug product stability, retest/expiry dating, storage condition justification, and ongoing stability commitments. 

• Working knowledge of ICH Q1A(R2), Q1B, Q1D, Q1E, Q5C, relevant FDA/EMA expectations, and phase-appropriate application of stability requirements. 

• Strong understanding of biologics product quality attributes. 

• Familiarity with analytical technologies used in biologics stability testing, including HPLC/UPLC, SEC, CE-SDS/cIEF/icIEF, ELISA, binding and potency assays. 

• Strong project management skills with the ability to manage detailed schedules, multiple vendors, cross-functional dependencies, and competing program priorities. 

• Ability to interpret stability trends, identify risks, escalate issues appropriately, and drive practical solutions in collaboration with technical and quality stakeholders. 

• Excellent documentation, communication, and stakeholder management skills. 

• Comfort with ambiguity and dynamic timelines; ability to operate independently and drive execution with limited supervision.