Process Optimization Manager Jobs in Ashburn, VA

Development and Manufacturing Interface

• Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products

• Communicate Manufacturing Operations needs to the CMC team, and ensure high-quality and timely program deliverables (comparability and validation study completion, etc)

• Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites

• Implement proactive process analysis and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites

Lifecycle Management

• Provide technical oversight across 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

• Contribute to post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks

• Proactively identify and mitigate technical and operational risks; ensure standardization across sites and teams

Regulatory & Quality Support

• Lead global Change Controls and ensure timely implementation and compliance

• Contribute to authoring 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

You will work in close partnership with:

• Late-Stage Process Development - provide MSAT input for process definition, improvements, and process characterization

• Site MS&T - partner to ensure timely implementation of process changes and improvements at the sites

• Quality - ensure process compliance and product quality standards

• Supply Chain - inform long-range supply planning and risk mitigation

Education

• B.S or 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 1+ years; OR M.S. with 5+ years, OR B.S. with 7+ 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.

• Background in GMP manufacturing operations and technology transfer. Experience in process validation and CPV desired.

• Experience in authoring 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.

The annual base pay for this position ranges from $96,196.80 - $144,295.20. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.