Senior Manager, Stability Management, Analytical Development and Quality Control

The Opportunity:

Playing a critical role as the subject matter expert (SME) on stability management, the position will be responsible for management of outsourced stability studies. The Sr. Manager, stability is a self-motivated individual who works as a member of an integrated team from design, management, and evaluation stability studies outsourced to contract organization. This individual should have the breadth of experience and knowledge required to support commercial, late and early clinical development stage.  This individual should have good understanding of  ICH and cGMP guidelines and the ability to contribute to global regulatory filings for stability.

• Coordinate stability activities, including but not limited to monitor schedule, data entry, review and presentations/reports.

• Track stability studies, maintain stability database.

• Author and / or review stability related documents, including protocol, report, and memos.

• 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 contract organization.

• Manage sample shipment, 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.

Required Skills, Experience and Education:

• PhD in Chemistry, Pharmaceutical Sciences, or related discipline with 8+ years of industry experience; or MS with 10+ years, or BS with 12+ years.

• 6+ 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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