Description:

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

　　• Act as the QA representative on cross-functional product teams to integrate stability activities with project milestones.

　　• Support the design of stability protocols to ensure that they are aligned with program strategy and regulatory requirements.

　　• Ensure that stability studies are executed according to protocol.

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

　　• Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support resolution.

　　• Interpret stability results to support expiry, trending, and conditions of products.

　　• Support product stability related content in regulatory submission, including responses to questions and post-marketing.

　　• This position primarily interacts with analysts/associates/scientists/managers in QC and PD.

　　• Other QC related activities as assigned by management.

　　Additional Skills & Qualifications:

　　• 3+ 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 stability requirements

　　• High competence in cGMPs and ICH requirements

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

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.