MSAT Product Lifecyle Lead (Drug Product)

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.