Senior Manager, Stability Strategy

BioSpace; Novato (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

BioMarin in California is seeking a Senior Manager, Stability Strategy to own stability programs across development through commercialization. You will design and defend stability strategies for complex programs in a multi-modality environment, coordinating with QA, regulatory, and analytical teams.

The ideal candidate has 10+ years in biotech/pharma stability, strong data analysis skills, and experience with ICH guidelines and regulatory submissions.

Qualifications

• 10+ years in Biotechnology, Pharmaceutical, or other regulated industry.
• Demonstrated experience defining and managing stability programs across development and commercial phases.
• Strong experience interpreting stability data to support expiry and/or retest decisions.
• Experience participating in health authority inspections.

Responsibilities

• Own stability strategy for assigned products across development and commercial stages.
• Design and maintain stability programs including study conditions (ICH long term, intermediate, accelerated, stress).
• Define and defend strategies for complex scenarios including accelerated development and bracketing/matrixing.
• Ensure phase-appropriate alignment of stability strategies with product knowledge and regulatory expectations.
• Lead stability support for process changes, comparability assessments, technology transfers, and lifecycle management.
• Author and review stability reports for regulatory submissions.
• Lead investigations for deviations and quality events.
• Drive continuous improvement of stability processes for compliance and business needs.
• Coordinate with cross-functional teams to implement stability strategies.

Skills

Stability strategy

Data analysis

Statistical analysis

Regulatory submissions

Cross-functional collaboration

JMP

LIMS

Veeva

Education

BA/BS in Life Sciences

Advanced degree preferred

Tools

JMP

LIMS

Veeva

Job description

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.

These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Summary

The 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.

Responsibilities

Product Stability Program Execution

• 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.

Data Management and Analysis

• 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 CofAs 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

CMC Regulatory Submission Support

• 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 Annual Report, Canadian Yearly Biological Product report, and Brazil Annual Product Report
• Support responses to health authority questions and information requests
• Ensure all strategies align with ICH guidelines and applicable global regulatory requirements.

Cross-Functional Alignment

• Coordinate with other departments (such as External Quality, QC, Analytical, PQL) to ensure that stability testing is integrated in the product development process.
• Translate complex stability considerations into clear, actionable recommendations
• Drive alignment on strategy through scientific credibility and influence.
• Coordinate with other departments to ensure the stability strategy is properly executed, including placement of annual commitment batches into the stability program according to regulatory commitments.

Experience

Required Skills:

• 10+ years of experience within the Biotechnology, Pharmaceutical, or other highly regulated industry.
• Demonstrated experience defining and managing stability programs across development and commercial phases of the product lifecycle.
• Strong experience interpreting stability data to support expiry and/or retest decisions.
• Strong working knowledge of ICH guidelines, global regulatory expectations, and statistical approaches for stability analysis.
• Experience participating in health agency inspections.

Desired Skills

• 12+ years of experience within the Biotechnology and/or Pharmaceutical industry preferred, including at least 2 years in a stability role.
• Experience with multiple modalities (e.g. small molecules, biologics, oligonucleotides, etc.) strongly preferred.
• Experience managing stability programs with atypical strategies through development and into commercialization strongly preferred.
• Strong experience writing stability reports and summaries for inclusion in INDs, BLAs, and other regulatory submissions.
• Demonstrated ability to defend stability decisions to regulators.
• Excellent interpersonal and communication skills and ability to influence diverse stakeholders to drive cross-functional decision-making.
• Proficiency with Veeva, LIMS, and JMP strongly preferred.

EDUCATION

BA/BS in Life Sciences or related field required. Advanced degree preferred.

CONTACTS

Interacts with Product Quality Leads, Supply Chain, Site QC, External Quality, Global External Operations, and Analytical Partner Leads.

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