Director, MSAT
$200,000–$250,000 year
On-site · Cambridge, Massachusetts, United States
Job Summary
Lead a MSAT team to support Phase I manufacturing of PSC-derived pancreatic islet cells for a cell therapy program; oversee technology transfer with an external partner and collaborate across Quality, External Manufacturing, and Supply Chain; author CMC sections of regulatory filings (IND module 3); manage manufacturing readiness, operator training, deviations investigations, and process improvements; engage with cross-functional teams and external partners to ensure timely delivery and quality in a fast-paced, matrix environment; travel ~25% to Canada and work in a cleanroom setting.
Required Qualifications
- BSc. in Chemical, Biological, or Biomedical Engineering plus 10 yrs or equivalent combination of education and work experience
- Experience managing a team of >3 direct reports
- Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator
- Travel to the manufacturing site ~25% of the time (Canada)
- Some weekend work required
- Lift up to 25 lbs
- Work within a cleanroom environment
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