Associate Director, MSAT
Sana Biotechnology, Inc.
June 30, 2026
Remote friendly (Cambridge, MA)
United States
$170,000 - $210,000 USD yearly
Operations
What you’ll do
- Lead a team of 1–2 individuals supporting phase I manufacturing of a PSC-derived pancreatic islet cell therapy product.
- Partner with the CDMO technical team to achieve phase I manufacturing readiness and address manufacturing challenges.
- Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution.
- Draft CMC sections for regulatory filings (IND module 3) and other technical documents.
- Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements.
- Lead investigations and troubleshoot process execution challenges using root cause analysis.
- Perform comparability studies with Research and PD teams to assess technology transfer success.
- Provide and receive feedback to support team growth and development.
- Influence multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
- Drive curiosity, scientific rigor, and problem-solving in a fast-paced, performance-driven environment.
- Assess talent to grow the organization and strengthen company culture.
What we’re looking for
- BSc in Chemical, Biological, or Biomedical Engineering plus 8 years (or equivalent education/work experience).
- 3+ years supporting early phase cell therapy manufacturing, including technology transfers.
- cGMP experience in regulated environments (including person-in-plant and/or GMP operator/supervisor).
- Experience operating perfusion bioreactors and fill/finish unit operations.
- Knowledge of PSC culture and differentiation biology to pancreatic islets.
- Experience managing a team of 2+ direct reports.
- Detail-oriented; strong problem-solving, technical writing, and verbal communication.
- Ability to work in multidisciplinary teams, meet deadlines, and prioritize multiple projects.
- Comfortable in a self-driven, fast-paced matrix environment.
Benefits/Pay (if part of job description)
- Base pay range: $170,000–$210,000/year.
Travel/Work Conditions
- Travel to manufacturing site ~25% (Texas); some weekend work; lift up to 25 lbs; work in a cleanroom.
Preferred
- Experience with key cell therapy equipment/unit ops for phase 1 trials (including PBS bioreactor).
- Familiarity with cell therapy drug product development (including stability studies).
- Working knowledge of DoE and RCA; grade B/ISO 7 cleanroom experience.
- Knowledge of single-use technologies; process closure/automation.
- Analytical methods (e.g., flow cytometry) and data tools (R, Python, JMP, FlowJo).
- Lead a team of 1–2 individuals supporting phase I manufacturing of a PSC-derived pancreatic islet cell therapy product.
- Partner with the CDMO technical team to achieve phase I manufacturing readiness and address manufacturing challenges.
- Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution.
- Draft CMC sections for regulatory filings (IND module 3) and other technical documents.
- Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements.
- Lead investigations and troubleshoot process execution challenges using root cause analysis.
- Perform comparability studies with Research and PD teams to assess technology transfer success.
- Provide and receive feedback to support team growth and development.
- Influence multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
- Drive curiosity, scientific rigor, and problem-solving in a fast-paced, performance-driven environment.
- Assess talent to grow the organization and strengthen company culture.
What we’re looking for
- BSc in Chemical, Biological, or Biomedical Engineering plus 8 years (or equivalent education/work experience).
- 3+ years supporting early phase cell therapy manufacturing, including technology transfers.
- cGMP experience in regulated environments (including person-in-plant and/or GMP operator/supervisor).
- Experience operating perfusion bioreactors and fill/finish unit operations.
- Knowledge of PSC culture and differentiation biology to pancreatic islets.
- Experience managing a team of 2+ direct reports.
- Detail-oriented; strong problem-solving, technical writing, and verbal communication.
- Ability to work in multidisciplinary teams, meet deadlines, and prioritize multiple projects.
- Comfortable in a self-driven, fast-paced matrix environment.
Benefits/Pay (if part of job description)
- Base pay range: $170,000–$210,000/year.
Travel/Work Conditions
- Travel to manufacturing site ~25% (Texas); some weekend work; lift up to 25 lbs; work in a cleanroom.
Preferred
- Experience with key cell therapy equipment/unit ops for phase 1 trials (including PBS bioreactor).
- Familiarity with cell therapy drug product development (including stability studies).
- Working knowledge of DoE and RCA; grade B/ISO 7 cleanroom experience.
- Knowledge of single-use technologies; process closure/automation.
- Analytical methods (e.g., flow cytometry) and data tools (R, Python, JMP, FlowJo).