Director, MSAT

Sana Biotechnology • Cambridge, MA

6h • $200,000 - $250,000

About The Position

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As an MSAT Director, you will report to the Executive Director of MSAT and support manufacturing of Sana’s stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). You will lead an MSAT team responsible for the PSC seed train and differentiation to beta cells at an external partner. You will define and execute the technology transfer strategy in alignment with program timelines and provide your team with technical mentorship. Your team will provide technical coverage at an external manufacturing partner throughout the phase I manufacturing campaign including people-in-plant, executed batch record review, investigations, and batch summaries. You will collaborate with internal partners across Quality, External Manufacturing, and Supply Chain to complete batch disposition. You will draft applicable CMC sections of regulatory documents (IND module 3).

Requirements

• BSc. in Chemical, Biological, or Biomedical Engineering plus 10 yrs or equivalent combination of education and work experience
• >5 year experience supporting early phase cell therapy manufacturing including technology transfers
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of >3 direct reports
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

Nice To Haves

• Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials including cryopreservation
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom
• Understanding of analytical methods such as flow cytometry
• Experience with cell therapy process closure and automation
• Knowledge of single-use technologies as applicable to cell therapies
• Familiar with data analysis tools such as R, Python, JMP and FlowJo software

Responsibilities

• Lead a team of 2-4 individuals supporting Phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
• Partner with CDMO technical team to achieve manufacturing readiness and address technical challenges
• Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution
• Author 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 including root cause analysis
• Perform comparability studies in collaboration with Research and PD teams to assess technology transfer success
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

Benefits

• Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable.
• We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.
• For more details on our benefits, visit Sana’s Benefits Portal.

What This Job Offers

• Job Type: Full-time
• Career Level: Director