Sr. Process Engineer (MS&T) at Genetix Biotherapeutics

Somerville, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Jun, 26

Salary

0.0

Posted On

10 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Characterization, Process Validation, Comparability, Continued Process Verification, Yield Improvement, Cost-of-Goods Reduction, Deviation Investigation, Root Cause Analysis, GMP Manufacturing, Technology Transfer, CDMO Management, Regulatory Filings, cGMP Knowledge, GDP Knowledge, ICH Guidelines, Cross-Functional Leadership

Industry

Biotechnology Research

Description

About Genetix Biotherapeutics At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values: Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care. SUMMARY 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. RESPONSIBILITIES MS&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/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). Cross-Functional Collaboration 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 Leadership & Collaboration 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 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 cell therapy 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 Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Responsibilities

The Senior Process Engineer acts as a technical leader responsible for sustaining, improving, and scaling GMP manufacturing processes for cell and gene therapy products, serving as a key process owner across the product lifecycle. Responsibilities include leading MS&T activities like process characterization and validation, providing real-time technical support for GMP operations, and collaborating cross-functionally to ensure process robustness and compliance.