Position Summary
- Lead and oversee Cell Therapy Manufacturing activities to ensure scheduled daily operations are completed on time and in accordance with Quality and Regulatory requirements.
Schedule
- In-office Wednesday–Saturday (Burlington, MA); some days in Cambridge, MA during transition.
Responsibilities
- Provide ethical leadership to manufacturing teams (cGMP; corporate quality governance).
- Train/qualify staff; ensure performance in an ISO Class 7 cleanroom (SOPs, cGMPs, safety) in an audit-ready state.
- Lead/coach technicians; develop work plans; assign tasks; conduct annual reviews and provide feedback; perform culture checks.
- Observe operations and provide constructive feedback; report inconsistencies/events and implement remediation guidance.
- Recommend improvements; support cross-training program; reconcile/approve direct-report time and manage OT within budget.
- Enter batch-record data into databases; assist with deviations, CAPA, risk assessments, and change controls.
- Be in the cleanroom for most daily operations; cover early/closing duties and lab monitoring.
- Serve as technical resource; perform aseptic cell culture manipulations; document production in electronic batch records/paper logs.
Qualifications (Required)
- Bachelor’s (Life Sciences/related) with 2–4+ years cGMP biotech/pharma experience; OR biotech certificate with 4–6+ years cGMP experience; OR GED + 8–10+ years cGMP experience.
- Proficiency in aseptic operations; ability to lead a team; hands-on aseptic cGMP experience.
- Qualified On-the-Job Trainer (at least one aseptic process).
- TrackWise (or equivalent) and solid MS Office knowledge.
Preferred
- Recognized for aseptic mastery and continuous improvement; experience in frequently audited regulated environments; excellent written/verbal communication.
Compensation
- $32.00–$39.00/hour (plus possible bonus/incentive/equity/benefits per posting).