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System One Stability Program Management Manager in Bothell, Washington

Title: Stability Program Management Manager

Location: Bothell, WA

Start date: ASAP

Responsibilities:

  • The Stability function is part of the Quality Control unit and is responsible for the design, governance, and operation of harmonized, compliant, and state of the art stability programs.

  • The stability function and Manager ensure stability strategy is integrated into the broader program strategy.

  • The Stability Manager is focused on managing the stability program for ADC GMP intermediates (mAb and drug linker), drug substance, drug product intermediates and drug product for clinical and commercial programs.

  • This individual acts as stability subject matter expert for their assigned program(s) and for stability quality processes and systems.

  • This individual may lead or support projects for stability program management or related quality continuous improvement.

  • The qualified person has a strong knowledge of global stability requirements, including studies required to support development, commercialization, and expiry strategy.

  • Lifecycle management of the stability program for clinical and commercial products

  • Act as representative on cross-functional quality or technical product teams to integrate stability activities with project milestones

  • Design stability protocols aligned with program strategy and regulatory requirements and ensure stability studies executed according to protocol

  • Interpretation of stability results to support expiry, trending, and conditions of real-world use

  • Report stability findings and conclusions for studies including annual batch, temperature cycling, photostability, reconstitution, and comparability studies in written reports and presentation form

  • Review, verification, disposition, and archival of stability study data for assigned programs

  • Responsible for product stability related sections in regulatory submission, including responses to questions and post-marketing commitment support.

  • Escalates unexpected data trends, OOS events, and risks appropriately, and drives/supports resolution.

  • This position primarily interacts with analysts/associates/scientists/managers in TOPS within the company and/or CMO/CTL quality organizations. In addition, some interactions with partners may occur.

Requirements:

  • 12+ years relevant experience in the biotech or pharmaceutical industry

  • BS/BA in a relevant field

  • Prior experience with stability program management or stability testing in a commercial or development environment

  • Experience with global stability requirements

  • High competence in cGMPs and ICH requirements

  • Strong scientific background and experience in the assessment of technical data and scientific information

  • Prior knowledge and experience with the application of statistics for stability design and data evaluation

  • Experience with CMC regulatory filings, global health authority interactions (e.g., inspections, meetings, Q&A interactions, etc.)

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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