Principal Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical Operations

About the role

This position is responsible for the technical oversight of robust, compliant, and cost-effective end-to-end cell therapy manufacturing processes. The role reports to the Associate Director, Global MS&T, is based in Gaithersburg, MD, and follows an onsite work model with up to 15% domestic and international travel.

Responsibilities

• Development and Manufacturing Interface
  • Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products.
  • Represent Manufacturing Operations on product CMC teams, ensuring high-quality and timely program deliverables (clinical & commercial supply, site approvals).
  • Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites.
  • Develop proactive process analysis and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control.
• Lifecycle Management
  • Provide technical oversight across the cell therapy manufacturing lifecycle—from pivotal manufacturing technology transfer, process validation, commercialization, and post-approval.
  • Identify and implement process improvements that increase process robustness, cost of goods, plant throughput, and supply continuity.
  • Manage post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks.
  • Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams.
• Regulatory & Quality Support
  • Lead global Change Controls and ensure timely implementation and compliance.
  • Author CMC sections of regulatory submissions—Pivotal INDa, BLA, MAA, and supplements—with high efficiency and optimal content.
  • Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations.
  • Develop and defend sound scientific justifications for the integrated control strategy and lifecycle changes.
• Cross-Functional Partnerships
  • Work closely with Late-Stage Process Development to ensure process definition, improvements, and process characterization reflect lifecycle strategy.
  • Partner with Site MS&T to ensure timely implementation of process changes and improvements at the sites.
  • Collaborate with Quality to ensure process compliance and product quality standards.
  • Align with CMC Regulatory on submission strategy and regulatory positioning.
  • Inform Supply Chain for long-range supply planning and risk mitigation.
  • Provide MSAT input for late-stage development and commercial readiness to CMC Leadership.

Qualifications

• Education
  • B.S, M.S., or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred.
• Experience
  • Ph.D. with 4+ years; OR M.S. with 8+ years; OR B.S. with 10+ years of relevant cell therapy/biologics/vaccines industry experience in technical development, MS&T, or CMO management areas.
  • Technical and hands-on expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in viral vectors, vaccines, or biologics will be considered.
  • Extensive background in GMP manufacturing operations and technology transfer. Experience in process validation and CPV.
  • Experience in authoring and defending CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections.
  • High standards of quality, accountability, and urgency—with the resilience to thrive in a fast-paced cell & gene therapy field.

Pay

The annual base pay for this position ranges from $122,312.80 to $183,469.20. The role offers eligibility for various incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.