Director, Stability Management, Analytical Development and Quality Control

The Opportunity:

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.

• Compile stability study results, perform trend and statistical analyses, and prepare reports to support retest/shelf-life date extensions and storage condition recommendations.

• Partner with quality during stability quality events (QEs) or investigations and implementation of CAPAs at contractors.

• Serve as the primary point of contact for contract organization for all stability related activities.

• Oversee sample shipment if applicable, inventory tracking, and chain of custody for stability studies.

• Support, author CMC stability documentation for IND, NDA, AR and IMPD filings, covering all phases of clinical development and commercial activities by ensure completeness and accuracy of stability data.

• Drive continuous improvement of stability management processes, including contract organization performance metrics.

• Collaborate cross-functionally with teams in drug substance, drug product, supply chain, quality, regulatory, sourcing and other related team to ensure alignment of stability design and achieve stability study objectives.

Required Skills, Experience and Education:

• PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 12+ years of industry experience; or MS with 15+ years, or BS with 18+ years.

• 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.

• Excellent leadership, people/team management, project management, and cross-functional collaboration skills.

• Strong problem-solving skills with strategic and technically sound decision-making ability.

• Excellent written and verbal communication skills and interpersonal skills.

• Energetic, team-oriented, and adaptable to a fast-paced, dynamic environment.

Preferred Skills:

• Experience with small molecule oncology drug development. 

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