Stability Program Manager

Description:

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

Principal Responsibilities

• 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 Seagen and/or CMO/CTL quality organizations. In addition, some interactions with partners may occur.

Additional Skills & Qualifications:

• 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

Preferred Qualifications

• 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.)

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.