Senior Manager, Stability Strategy

Senior Manager, Stability Strategy is a senior individual contributor responsible for defining and owning stability strategies for assigned products across the product lifecycle (development through commercialization). This role operates as a product- aligned stability subject matter expert and is expected to independently design, justify, and defend stability strategies under conditions of complexity and ambiguity.

The ideal candidate brings extensive experience in stability within the pharmaceutical or biotechnology industry, with the ability to operate in a multi-modality environment and lead complex investigations and cross-functional initiatives.

• Serve as primary owner of stability strategy for assigned products across development and commercial stages.
• Design and maintain stability programs including choice of study conditions (ICH long term, intermediate, accelerated, stress), testing strategies, and bracketing and matrixing approaches.
• Independently define and defend strategies for complex scenarios including accelerated development approaches, reduced testing design (bracketing/matrixing), SKU coverage and bridging strategies.
• Ensure phase-appropriate alignment of stability strategies with product knowledge, supply considerations, and regulatory expectations.
• Lead stability strategy support for process changes and comparability assessments, technology transfers, and lifecycle management activities, including post-approval changes.
• Make risk-based decisions in the absence of clear regulatory or industry precedent.
• Author and review stability reports and summaries for inclusion in INDs, BLAs, Annual Reports, and other regulatory submissions.
• Lead investigations for significant deviations and quality events, including those at external testing laboratories, ensuring timely and compliant resolution.
• Drive continuous improvement of processes to maintain compliance while supporting operational and commercial needs.
• Author and review technical documentation, including protocols, reports, SOPs, test methods, and risk/impact assessments.
• Initiate and own Quality Management System (QMS) records such as deviations, change controls, and CAPAs related to the stability program.

• Analyze and interpret stability data to establish and justify expiry and retest periods, assess degradation pathways and product risk, support storage and shipping condition recommendations, including allowable excursions.
• Identify emerging trends and risks and proactively drive mitigation strategies.
• Support the generation, maintenance, and reporting of stability data for clinical and commercial programs, including drug substance, drug product, and critical intermediates.
• Oversee the collection and analysis of stability data and interpreting results to identify potential issues or trends; this includes accessing data from LIMS or Cof As and performing data analysis in data trending software (such as JMP) to generate and support conclusions in technical documentation.
• Perform statistical analysis to provide shelf-life projections, support proposals for end-of-shelf-life specifications and monitor the performance of stability batches using statistical analysis to detect potential adverse trends which may need to be investigated.
• Partner with the Product Quality Leaders (PQLs) to perform the statistical calculations needed to set acceptance criteria for product comparability.

• Author and review stability sections for global regulatory submissions (e.g. IND/CTA, NDA/BLA, MAA, post-approval changes).
• Author annual report sections with stability summaries and data for regulatory submissions including but not limited to the US…