Stability Strategy Lead for Biotech & Pharma

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

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