Sr. Manufacturing Specialist

Genetix Biotherapeutics•Somerville, MA

1d•$105,000 - $120,000•Hybrid

About The Position

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.

Requirements

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 organizational skills.
Eagerness to learn and take on increasing responsibility in MS&T.

Nice To Haves

Experience in cell and gene therapy or biologics preferred.
Familiarity with regulatory requirements (FDA, EMA, ICH) is a plus.

Responsibilities

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 escalate 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 optimization, 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.