Remote Senior Stability Strategy Lead

BioMarin Pharmaceutical Inc.

Novato (CA)

Remote

USD 170,000 - 210,000

Full time

14 days+

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Job summary

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

You will design, defend, and optimize stability strategies, coordinating with cross-functional teams to ensure regulatory alignment and robust data support for submissions. The ideal candidate brings 10+ years in biotech/pharma stability, expertise in ICH guidelines, and experience with regulatory inspections.

Qualifications

10+ years of experience in biotech/pharma stability.
Defined and managed stability programs across development and commercialization.
Experience interpreting stability data to support expiry/retest decisions.
Experience participating in health agency 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).
Defend stability strategies for complex scenarios including accelerated development approaches, bracketing/matrixing.
Ensure phase-appropriate alignment of stability strategies with knowledge, supply, and regulatory expectations.
Lead stability support for process changes and comparability assessments, technology transfers, and lifecycle activities.
Make risk-based decisions in absence of clear regulatory precedent.
Author/review stability reports for regulatory submissions (INDs, BLAs, etc.).
Lead investigations for deviations and quality events with external labs.
Drive continuous improvement of stability processes for compliance.
Author/review technical documentation and QMS records related to stability.