Principal Engineer, MSAT

This is a fully remote position, open to applicants in Kentucky, +13 more states.

📋 Description

• Spearhead the technical execution of comparability strategies for commercial-stage projects, facilitating site transfers, process adjustments, equipment modifications, or material changes.

• Design and oversee technical workstreams related to late-stage and commercial process modifications at GMP facilities.

• Perform technical risk assessments, manage change controls, conduct impact assessments, and assess comparability considerations alongside GMP implementation.

• Direct late-stage and commercial technology transfer workstreams, encompassing transfer planning, facility/process fit evaluation, risk assessments, training, engineering runs, comparability, process implementation, and GMP readiness.

• Take ownership of or assist in developing technology transfer packages, change controls, technical risk assessments, comparability plans, data packages, reports, process control strategies, execution protocols, batch records, and regulatory source documents.

• Provide on-site support for process improvement (PiP), resolve process issues, and lead technical investigations, deviations, change controls, and CAPAs to successful resolution.

• Establish and assess manufacturing data along with process performance trends utilizing statistical tools.

• Detect variability, shifts, and potential enhancements to bolster process consistency, yield, robustness, and compliance.

• Oversee deviation and change-control impact assessments, conduct root-cause analyses, and ensure the timely closure of tech transfer investigations.

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

• Ensure the development of effective business continuity plans.

• Act as a technical and GMP subject matter expert within cross-functional technical execution teams.

• Partner with GMP manufacturing sites to implement and maintain robust, compliant commercial manufacturing processes.

⛳️ Requirements

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

• 10+ years of relevant industry experience with a B.S.; 7+ years with an M.S.; or 5+ years with a Ph.D.

• Extensive experience in MSAT, Manufacturing, Process Development, or related fields that support late-stage or commercial biologics or cell therapies.

• Proven experience in commercial-stage comparability, including that which supports manufacturing site transfers, process, equipment, or material modifications, as well as other post-approval/lifecycle manufacturing changes.

• Demonstrated ability to lead late-stage or commercial technology transfer workstreams and collaborate directly with GMP manufacturing sites.

• Familiarity with engineering/GMP manufacturing, validation/PPQ, technical deviations, and manufacturing investigations.

• Experience in drafting risk assessments, technical documentation, and source documents for CMC regulatory submissions.

• Previous experience supporting regulatory responses or inspections is preferred.

• Expertise in leading cross-functional technical subteams and guiding GMP manufacturing partners through intricate technical challenges and implementations.

• Cell therapy experience is highly desirable.

• Experience across multiple commercial manufacturing sites or products is a benefit.

• Strong grasp of GMPs, ICH guidelines, and regulatory expectations for cell therapies.

• In-depth knowledge of technology transfer, commercial comparability, GMP manufacturing, validation/PPQ, process control strategies, deviation/change control, and commercial lifecycle management.

• Capability to independently manage complex technical workstreams, implement commercial lifecycle changes, and devise technical strategies with minimal guidance.

• Excellent technical writing and document review abilities.

• Strong analytical, troubleshooting, and data analysis skills.

• Ability to lead cross-functional technical subteams, influence external manufacturing partners, and mentor junior technical personnel without direct management authority.

• Background in cell therapy, viral vector, or other complex biologic modalities with practical GMP manufacturing experience is preferred.

• 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).

• Paid parking facilities.

• Subsidized commuter passes.

• In-office catered lunches.

• Team-building events.

• Opportunities for community projects.

• Competitive compensation packages.