Director, Cell Therapy Drug Product Process Development

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 want to challenge status quo, and who lead with the desire to work on novel ideas. Reporting to the Head of Cell Therapy Process Development, the Director of Cell Therapy Drug Product Development will be responsible for establishing formulation, fill/finish, and cryopreservation processes for CAR T and stem cell derived products. The role entails leading and mentoring a strong technical team to innovate and develop industry-leading formulation and drug product processes to enable cell therapy clinical manufacturing.

What you’ll do

• Provide strategic and technical leadership for the development of formulation/fill/finish and cryopreservation processes used to manufacturing of Sana’s cell therapy pipeline
• Accountable for the execution of drug product process-enabling studies including formulation, fill/finish, cryopreservation, thawing, and in-use compatibility study for candidate cell therapy products
• Manage and mentor the Drug Product development group by engaging in crucial conversations, supporting their technical and leadership development, career interests, help balance workload and clarify priorities
• Review and author technical documents including reports, process descriptions, SOPs, MBRs, and relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents
• Collaborate with PD, MSAT, Supply Chain, and Quality teams to support tech transfer activities, GMP manufacturing for fill/finish/cryopreservation steps and GMP investigations.
• Serve as the formulation, cryopreservation and drug product subject matter expert on cross-functional teams
• As a member of the Tech Ops Cell Therapy Process Development Leadership Team, help develop the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work
• 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 

• PhD in scientific discipline w 8+ yrs experience in academic research and/or industry. BA or MS plus 10+ yrs or equivalent combination of education and work experience
• Experience leveraging statistical Design of Experiments (DoE) strategies
• Progressive years of industry experience in cell therapy drug product process development and/or manufacturing, including formulation, filling, finish, and cryopreservation
• Proven ability to build, manage and mentor a team of talented scientists and engineers
• Prior experience working on a clinical or commercial cell therapy manufacturing process
• Extensive hands-on experience in formulation development and designing and scaling fill/finish and cryopreservation processes, such as aseptic filling and controlled-rate freezing
• Well versed with cGMP requirements and working in a regulated environment
• Detail-oriented with excellent problem-solving, technical writing and verbal communication skills
• Ability to work effectively within cross-functional teams, influence collaborators and stakeholders, and prioritize across multiple projects
• Aptitude for working in a self-motivated, performance/results-oriented, fast-paced matrix environment to achieve goals 

What will separate you from the crowd

• Experience with cell cryopreservation (single cells and aggregates)
• Experience with automated liquid handlers and mechanical aptitude for troubleshooting instrumentation
• Working knowledge of JMP or other statistical analysis software

What you should know

• Working safely in person on a predictable and regular basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19
• The base pay range for this position at commencement of employment is expected to be between $190,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together

• Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution 

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

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 100% of the cost for employee health coverage and offer generous 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.

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.