SUMMARYThe
Sr. Process Engineer MS&T - LVV Manufacturing is a technical leader responsible for sustaining, improving, and scaling GMP processes for Lentiviral Vector (LVV) manufacturing. This role serves as a key process owner across the product lifecycle, providing hands-on technical support for commercial manufacturing, technology transfer 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.RESPONSIBILITIESMS&T Leadership- 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 LVV 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).
Cross-Functional Collaboration- Act as a key technical interface with Quality, Regulatory Affairs, Analytical, and External Manufacturing partners
- Support regulatory filings, responses, and lifecycle submissions
- Support technology transferactivities between development and external CDMOs.
- Collaborate with Quality and Regulatory teams to support inspections, audits, and regulatory submissions
- Represent LVV manufacturing in governance forums and senior leadership discussions
Leadership & Collaboration- Support the overall CMC and manufacturing strategy for LVV production
- Collaborate closely with a CDMO network for technical support for manufacturing activities
- Establish a strong culture of accountability, continuous improvement, and technical rigor
QUALIFICATIONS Education and Experience- 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 LVV manufacturing
- Strategic thinker with strong technical skills and a hands-on operational leader
Skills and Competencies- 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
