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MSAT Product Lifecyle Lead (Drug Product)

Job

Germer International - Pharmaceutical Recruiting

Berwyn, PA (In Person)

Full-Time

Posted 4 days ago (Updated 1 day ago) • Actively hiring

Expires 7/22/2026

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Job Description

MSAT Product Lifecyle Lead (Drug Product) at Germer International - Pharmaceutical Recruiting MSAT Product Lifecyle Lead (Drug Product) at Germer International - Pharmaceutical Recruiting in Berwyn, Pennsylvania Posted in about 14 hours ago.
Type:
full-time
Job Description:
This role requires a strong technical background across multiple scientific disciplines and manufacturing/validation fundamentals, including biopharmaceutical best practices, statistical analysis, and regulatory requirements for validation. The role also involves cross-functional collaboration with MSAT leadership, Manufacturing, Quality, and customers to develop and execute the process validation strategy. Primary Responsibilities Responsible for change control impact assessments, investigations, and other quality system deliverables. Lead commercial readiness strategies to ensure smooth, efficient, and compliant gene therapy product lifecycles. Lead process validation and PPQ activities. Perform process risk assessments (e.g., FMEA) and comprehensive gap assessments to identify manufacturing vulnerabilities, regulatory misalignments, or opportunities for optimization. Lead and evaluate the management of raw materials, single-use components, and material attributes critical to gene therapy product quality and stability. Author, implement, and continuously update SOPs, batch records, and tech transfer documentation to maintain an up-to-date and compliant operational framework. Collect and analyze lifecycle process data to monitor trends, identify variations, and support continued process verification (CPV). Contribute to cross-functional lifecycle management teams and develop technical leadership skills. Education & Experience BS (7+ years experience), MS (3+ years experience), or PhD (0-2 years experience) in Chemical Engineering, Biomedical Engineering, Biology, or a related life sciences field. Experience in drug product formulation and filling technologies with demonstrated laboratory proficiency.