Scientist, Cell Therapy Process Development
About the role
Sana has an exciting opportunity within the Cell Therapy Process Development group for a talented, motivated, and detailed oriented Scientist. You will have a critical role in developing a production scale pluripotent stem cell-derived beta islet manufacturing process. In this role, you will also play an important role in transferring the process to the manufacturing facility, to enable Beta islet cell clinical product manufacturing.
Reporting to the Group Leader, Process Development - Cell Banking, you will join an innovative multi-disciplinary team developing cell therapy manufacturing technologies to bring allogeneic PSC-derived beta cell therapies into clinical trials.
What you’ll do
- Play a key role in the development, optimization, and characterization of an at-scale PSC-based Beta Islet differentiation process
- Collaborate closely with Beta cell research program and Hypo-immune PSC development program. Advise both programs on CMC considerations
- Maintain a functioning Beta Islet cell therapy PD lab
- Develop workflows compatible with a cGMP environment
- Draft process transfer packages and other technical documents including SOPs, Master Batch Records, Bills of Material, Sampling Plans in close collaboration with the CMC and Process leads
- Tech transfer processes to other Sana sites and external manufacturing organizations. Provide onsite support at the CDMO, train new operators, and oversee process execution
What we’re looking for
- PhD in scientific discipline plus 2 yrs, or BA and/or MS plus 7+ yrs or equivalent combination of education and work experience
- Deep knowledge of Developmental Biology, including stem cell biology, and preferably knowledge and understanding of Beta islet stem cell biology and differentiation
- Hands-on experience with stem cell culture and differentiation, including understanding of the cell culture media and matrix systems
- Track record of applying fundamental scientific principles to process design and characterization, preferably in Beta Islet Cell therapy industry context
- Versed with cGMP requirements and working in a regulated environment
- The candidate should be, highly organized and demonstrate curiosity and scientific rigor and excellent problem-solving skills
- Effective collaborator with an agile mindset to thrive in a fast-paced, multi-site, team-oriented organization
- Ability to engage in crucial conversations – providing and receiving feedback
What will separate you from the crowd
- Knowledge and experience with Beta Islet Cell differentiation
- Direct, hands-on industrial experience with biologics, gene, and/or cell therapy process development
- Hands-on experience with bioreactor unit operations at bench and pilot scale
- Working knowledge of DoE methods for experimentation and statistical analysis
- cGMP manufacturing experience, including tech transfer
- Experience in drafting process transfer packages and other technical documents including SOPs, Master Batch Records, Bills of Material
- Proficient with relevant analytical methods including flow cytometry and cell-based assays
- Understanding of the data package and reports required to advance processes into clinical manufacturing
What you should know
- This is a lab-based position
- Some weekend work required – have to be able to accommodate flexible working schedule
- This position requires handling human tissue-derived cells
- Travel up to 50% of the time (including East Coast sites)
- Work within a cleanroom environment
- Occasional bending and lifting smaller equipment and media (up to approximately 20kg)
- Lab work (standing and seated)
- Working safely on a predictable and regular basis is an essential job function for this position and the Company requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19
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, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.
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, 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.