Sr. Manufacturing Specialist

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.

The Senior Manufacturing Specialist, Manufacturing is a hands‑on individual contributor responsible for sustaining and improving the day‑to‑day performance of GMP manufacturing operations for our commercially approved cell and gene therapy products. Working closely with Manufacturing, MS&T, Quality, Supply Chain and external CMO partners, this role executes on shop‑floor technical support, continuous improvement initiatives and cost‑savings projects that directly contribute to yield improvement, cycle time reduction and right‑first‑time execution.

This role is ideal for an experienced manufacturing or operations professional who thrives in a technical, execution‑focused capacity and wants to make a meaningful impact.

This is a full‑time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

• Support technology transfer, process validation and continued process verification (CPV) activities at external CDMOs.
• Partner with MS&T and Process Development to implement process improvements and ensure operational feasibility.
• Provide hands‑on technical support during engineering, PPQ and commercial runs.

• Serve as a technical point‑of‑contact for GMP manufacturing operations, supporting batch execution, troubleshooting, and/or tech transfer.
• Author, review and revise GMP documentation including master batch records (MBRs), SOPs, work instructions and change controls.
• Support deviation investigations, perform root cause analysis and implement CAPAs in partnership with Quality and MS&T.
• Monitor process performance against established KPIs and elevate trends or risks to leadership.
• Execute on continuous improvement and value‑creation initiatives aligned with the manufacturing portfolio, including Lean, Kaizen and Six Sigma projects.
• Identify and implement cost‑savings opportunities at the shop‑floor level – including material optimisation, yield improvement and cycle‑time reduction.
• Lead or co‑lead process mapping and value‑stream mapping activities; document current‑state and future‑state workflows.
• Contribute to cost‑saving analyses and sourcing evaluations by providing operational and technical input.

• B.S. or M.S. in a scientific or engineering discipline.
• 4–8 years of experience in biopharma manufacturing, MS&T or CMC roles; experience in cell and gene therapy or biologics preferred.
• Experience with GMP manufacturing, technology transfer, process monitoring and process validation is preferred.
• Familiarity with regulatory requirements (FDA, EMA, ICH) is a plus.
• Strong technical problem‑solving and analytical skills.
• Ability to collaborate effectively across multiple teams and disciplines.
• Knowledge of cGMP, GDP and regulatory requirements.
• Hands‑on operational experience in manufacturing processes.
• Effective communication, documentation and organisational skills.
• Eagerness to learn and take on increasing responsibility in MS&T.

$105,000 - $120,000 USD

The pay transparency range provided below 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…