Senior Principal Engineer, MSAT

This is a fully remote position, open to applicants in Kentucky, +11 more states.

📋 Description

• Lead one or multiple technology transfers to manufacturing facilities supporting late-stage clinical and commercial initiatives.

• Oversee the implementation of CMC strategies and manage CDMOs during technology transfer processes.

• Direct new site or suite readiness, conduct risk assessments, formulate tech transfer strategies, plan risk mitigation, and oversee feasibility studies, engineering runs, comparability assessments, and PPQ runs.

• Offer strategic insights and contribute to the authorship of CMC regulatory submission sections.

• Provide immediate response support as necessary.

• Collaborate with manufacturing sites to ensure that technology, equipment, personnel, and documentation facilitate continuous GMP manufacturing.

• Ensure the development of effective business continuity plans.

• Assist in the execution of GMP manufacturing, including maintaining an on-site presence during initial campaigns, PiP, troubleshooting, and driving investigations to resolution.

• Oversee or assist in process control strategies, technology transfer plans, batch records, risk assessments, comparability evaluations, and change controls.

• Coordinate cross-functional execution with Process Development, Process Sciences, External Manufacturing, Manufacturing Validations, Quality, Regulatory, and Supply Chain teams.

• Facilitate technology transfers to achieve GMP commercial readiness within accelerated timelines.

• Establish systems for manufacturing data capture and ongoing trend analysis.

• Execute data and statistical analyses using JMP as required.

• Lead deviation and change-control impact assessments, perform root-cause analyses, and ensure the closure of GMP investigations.

• Monitor performance metrics for Drug Substance and Drug Product and recommend enhancements for process consistency, yield, or compliance.

• Perform additional duties as assigned.

⛳️ Requirements

• A B.S., M.S., or Ph.D. degree in a scientific or engineering discipline is required.

• 12+ years of experience with a B.S., 10+ years with an M.S., or 6+ years with a Ph.D.

• A minimum of 5 years of experience in MS&T, Manufacturing, or Process Development for biologics or cell therapies.

• Proven experience in leading cross-functional teams, managing CDMOs, delegating responsibilities, and solving complex issues.

• Experience with late-stage and commercial cell therapy is required.

• Demonstrated ability to lead late-stage/commercial tech transfers, including CDMOs, process changes, technical deviations, comparability studies, and PPQ for cell therapies.

• Experience in authoring and defending CMC sections of regulatory submissions and during regulatory inspections.

• Strong understanding of GMPs, ICH guidelines, and regulatory expectations related to cell therapies.

• Background in cell therapy, viral vector, or other complex biologic modalities.

• Proven track record in managing new site tech transfers in a fast-paced environment.

• Strong analytical and problem-solving skills with a data-driven perspective.

• Expertise in deviation management, change control, and CAPA.

• Strong capabilities in technical writing and document review.

• Experience in problem-solving, process troubleshooting, and data analysis.

• Proficiency with project management tools and data analysis platforms such as JMP and Excel.

• Excellent communication and organizational skills, with the ability to manage multiple priorities.

• Willingness to travel up to 35% of the time.

🏝️ Benefits

• Comprehensive health insurance for employees and their families.

• 401(k) matching program.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Generous paid time off (PTO).

• Competitive compensation packages.

• Paid parking for employees.

• Subsidized commuter passes.

• In-office catered lunches.

• Team-building events.

• Opportunities for community engagement projects.