Senior Manager, Stability Strategy

BioMarin Pharmaceutical Inc.; United States; Remote; USD 125,000 - 172,000; Full time

Benefits offered by this job

Bonus eligibility

Stock-based incentives

Comprehensive benefits

Paid time off

Job summary

BioMarin Pharmaceutical Inc. is seeking a Senior Manager, Stability Strategy to own the stability program across development and commercialization.

You will design, defend, and implement stability strategies in a multi-modality setting, lead complex investigations, and ensure alignment with regulatory expectations while coordinating with PQLs, QA, and supply teams. The role emphasizes data-driven decisions, expertise in ICH guidelines, and collaboration to drive lifecycle management and

Qualifications

• 10+ years of stability experience in biotechnology/pharmaceutical industry.
• Experience defining and managing stability programs across development and commercialization.
• Strong knowledge of ICH guidelines and global regulatory expectations.
• Experience participating in health authority inspections.
• Proficiency with Veeva, LIMS and JMP.

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), testing strategies, and bracketing/matrixing approaches.
• Defend stability strategies for complex scenarios including accelerated development approaches and bridging strategies.
• Lead investigations for deviations and quality events, including external testing laboratories.
• Coordinate with cross-functional teams to align stability strategy with product knowledge, supply, and regulatory expectations.
• Author and review stability reports and summaries for regulatory submissions.
• Drive continuous improvement of stability processes and the QMS with related records.

Skills

Stability leadership

ICH guidelines

Regulatory know-how

Cross-functional collaboration

Data analysis

Education

BA/BS in Life Sciences

Tools

Veeva

LIMS

JMP

Job description

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.

SHIFT DETAILS

Office shift (M-F 8-5)

ONSITE, REMOTE, OR FLEXIBLE

The role does not require time on site. The role requires significant time in virtual meetings, as well as computer-based work (data analysis, document authoring/review), which can be successfully performed from home.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

The salary range for this position is: $124,800 to $171,600. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email [e-mail] with your request. This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team – please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at [e-mail]. Applicants, please do not use this email address to submit resumes – if you do so, you will be redirected to apply through the website.