Sr. Process Engineer, MS&T LVV Manufacturing
$109k - $145k USD
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 – 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.
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 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
Additional Information:
Base Salary Range: $108,571 - $144,611
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/ qualifications, external market, internal equity, and other job-related factors permitted by law.
Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.
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.