MSAT Product Lifecyle Lead

Job Description

Manufacturing Science & Technology (MSAT) is a department within the Manufacturing Operations Division. The MSAT Process Engineer – Product Lifecycle will serve as the technical lead for technology transfer, commercial readiness, process validation, and continuous lifecycle management of viral vector gene therapy products. This individual will spearhead commercial readiness strategies, process risk assessments (FMEA), comprehensive gap assessments, and the execution of Process Performance Qualification (PPQ) campaigns. The Lead Engineer will act as a subject matter expert (SME) for material sciences, author relevant sections of regulatory filings, and establish robust Standard Operating Procedures (SOPs) to ensure strict compliance with global GMP standards.

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.

Key Competencies

• Strong understanding of product lifecycle concepts, validation stages, and commercial readiness for advanced therapies.
• Ability to identify and solve routine process and material issues using structured risk assessment methodologies.
• High proficiency in documenting technical processes, drafting risk/gap reports, and establishing compliant SOPs.
• Effective written and verbal communication skills with the ability to present technical data to cross-functional teams.
• Strong teamwork and collaboration skills across MSAT, Quality, and Operations.
• Experience in technology transfer from development into cGMP manufacturing.
• Experience working within quality systems and authoring/reviewing GMP documentation.
• Preferred experience in facility commissioning, equipment qualification, and maintenance.
• Strong understanding of GMP requirements in relation to manufacturing operations.
• Demonstrated project management capabilities.
• Self-motivated with strong interpersonal and organizational skills.
• High emotional intelligence and ability to work with internal teams and clients.
• Ability to work in a fast-paced environment with shifting priorities.

Physical Requirements

• Prolonged periods of sitting and working on a computer.
• Ability to lift up to 15 pounds occasionally.
• Ability to stand/work in a lab or GMP environment for 4+ hours as needed.