Sr. Process Engineer (MS&T)
About The Position
The Sr. Process Engineer (MS&T) is a technical leader responsible for sustaining, improving, and scaling GMP manufacturing processes for cell and gene therapy products. This role serves as a key process owner across the product lifecycle, providing hands-on technical support for commercial manufacturing, technology transfer, process validation, and continuous improvement. You will partner closely with Manufacturing, Quality, Process Development, Analytical Development, Supply Chain, and external partners to ensure processes are compliant, robust, and capable of meeting commercial demand. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree
- 5+ years of experience in manufacturing, MS&T or CMC roles in the biopharma industry,
- Deep experience managing contract manufacturing and external supply networks in cell therapy manufacturing
- Strategic thinker with strong technical skills and a hands-on operational leader
- Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization
- Deep knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)
- Exceptional leadership, communication, and cross-functional collaboration skills
Responsibilities
- Lead or support MS&T activities including process characterization, validation, comparability, and continued process verification (CPV)
- Drive process robustness, yield improvement, and cost-of-goods reduction initiatives
- Provide technical leadership for process deviations, investigations, and root cause analysis
- Serve as process SME within MS&T for assigned unit operations and/or end-to-end manufacturing processes.
- Provide real-time technical support for GMP manufacturing operations, including investigation of deviations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
- Act as a key technical interface with Quality, Regulatory Affairs, Process Development, Analytical, and External Manufacturing partners
- Support regulatory filings, responses, and lifecycle submissions
- Support technology transfer activities between development and external CDMOs.
- Collaborate with Quality and Regulatory teams to support inspections, audits, and regulatory submissions
- Represent drug product manufacturing in governance forums and senior leadership discussions
- Support to the overall CMC and manufacturing strategy for commercial products
- Collaborate closely with CDMO and Manufacturing for technical support for manufacturing activities
- Establish a strong culture of accountability, continuous improvement, and technical rigor
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
