Director, Stability Management, Analytical Development and Quality Control

10+ years in stability management or relevant experience within pharmaceutical or biotech industry.

Strong knowledge of GMP regulations, quality systems, ICH guidelines, and regulatory expectations (FDA, EMA, etc.).

Extensive experience managing contract organization and working in a virtual development model.

Experience with small molecule oncology drug development.

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Playing a critical role as the stability program lead, the position will be responsible for oversight and management of outsourced stability studies conducted.

The director, stability  is a self-motivated individual who works as a member of an integrated team contracting, designing, managing, and evaluating stability studies at contractors for both drug substance and drug product.

This individual should have the breadth of experience required to manage stability studies in commercial, late and early clinical development stage.  This individual should have broad knowledge of ICH and cGMP guidelines and the ability to contribute to global regulatory filings for stability.

Develop and implement the strategic direction of stability programs in alignment with ICH guidelines and regulatory expectations.

Oversee the design, execution, and management of stability studies (development, registration and commercial).

Work cross functionally with CMC, quality, regulatory, clinical and related teams to achieve stability objectives.