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About the role

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 Associate Director, you will report to the Executive Director of MSAT to 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 pancreatic cell maturation and aggregation process to generate DP at an external manufacturing partner. You will define and execute the technology transfer strategy in alignment with program timelines. Your team will provide technical coverage at the 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).  You will provide your team members with technical guidance and mentorship.   

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 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 by applying 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

What we’re looking for

• BSc. in Chemical, Biological, or Biomedical Engineering plus 8 yrs or equivalent combination of education and work experience
• >3 year experience supporting early phase cell therapy manufacturing including technology transfers
• Well versed with cGMP requirements and experience working in a regulated environment, including as person-in-plan and/or GMP operator/supervisor
• Experience operating perfusion bioreactors and with fill/finish unit operations
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of >2 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

What will separate you from the crowd

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

What you should know

• Travel to the manufacturing site ~25% of the time (Texas)
• Some weekend work required
• Lift up to 25 lbs
• Work within a cleanroom environment
• The base pay range for this position at commencement of employment is expected to be between $170,000 and $210,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience