Director, MSAT

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).

What you’ll do

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

What we’re looking for

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

What will separate you from the crowd

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

What you should know

Travel to the manufacturing site ~25% of the time (Canada)

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 $200,000 and $250,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.

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