Biotech Senior Stability Strategy Leader

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

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.