Principal Scientist of Cell Characterization
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As the Principal Scientist (Director level) of cell product characterization, you will report to the Executive director of product characterization and analytical chemistry to build and lead a function accountable for establishing deep characterization and knowledge of novel T-Cell based products. You will also play an important scientific leadership role in the establishment of CMC control strategies for Sana's pipeline. The title will be in line with experience.
What you'll do
- As the leader, design characterization strategies to deliver impactful understanding of the T Cell product biology, heterogeneity and function to identify and justify critical quality attributes (CQAs)
- Act as a scientific leader for cellular immunology and T-Cell product characterization to guide process and analytical development, process understanding and the establishing of phase-appropriate control strategies
- Advance scientific understanding of T-Cell product CQAs and correlation to product efficacy and safety
- Partner with Research, Tech Sciences, Development Sciences and Clinical teams to advance T-Cell product characterization
- Author and review relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents
- As part of the LT in the department, create an inspiring vision for the T-Cell Product Characterization team
- Work with other Tech Ops stakeholders in PD/ADQC, Quality and Regulatory to set appropriate product specifications, develop comparability strategies and support manufacturing investigations
- Collaborate with internal and external stakeholders including health authorities and industry organizations to identify trends and expectations and incorporate them into Sana's CMC control strategies
- Establish regular interface and build strong connections with CMOs and contract labs in cellular product characterization
What we're looking for
- Ph.D. in Immunology, Cell Biology, or other related disciplines and 8+ years of experience in adoptive T-Cell based therapies. BA and/or MS with 10+ years or equivalent combination of education and work experience are considered
- Significant experience driving characterization of T-Cell therapy products to advance product understanding, process development and the establishment of control strategies
- Problem solver with the ability to use technologies to dive deeper and more broadly in advancing our knowledge in the field of T-Cell biology and function to support product and process development
- Significant prior experiences in advanced analytical platforms and related data analysis, e.g. immunoassays, multi-color flow cytometry and single cell analytical assays
- Demonstrated experience building and empowering teams; excellent ability to work collaboratively in a complex, matrix environment; demonstrated talent to foster team productivity and cohesiveness within the team
- Strong working knowledge and interpretation of FDA/EMA and ICH guidelines
- Proven track-record to collaborate effectively in a matrix environment and lead with curiosity and influence across functional and organizational lines
- Ability to effectively work through change
What will separate you from the crowd
- Significant experience of developing cellular therapy and insights of allogenic cell products development
- Passion for science and the drive for positively impact on patient’s life
- Strive for scientific excellence and focus on delivering results
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, 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.