Senior Engineer II/Associate Director, Cell Therapy Process Development

at  Sana Biotechnology

WHAT WILL SEPARATE YOU FROM THE CROWD

• Experience with process characterization of T cell isolation, lentiviral transduction, gene editing, cell harvest and cryopreservation unit operations design and model scaling
• Well versed with current cell therapy manufacturing platforms
• Working knowledge of statistical design of experiments (DoE)
• Experienced in establishing robust operating regions within phase-approach pre-defined acceptance criteria
• Knowledge designing and qualifying high throughput T cell culture scale down models
• Experience selecting raw materials and equipment suitable for cell therapy processes
• Familiarity applying PAT to cell therapy
• Familiar with R, Python, and JMP software
• Demonstrate intense technical curiosity and a continuous drive to learn new skills

WHAT YOU SHOULD KNOW

• This position requires handling of healthy donor human blood products
• Approximately 50% in-lab work
• Some weekend work required
• Travel up to 25% of the time
• The base pay range for this position at commencement of employment is expected to be between $170,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

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

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. As a Senior Process Engineer, you will report to the Sr. Director of Cell Therapy Process Development and drive late stage process development of allogeneic chimeric antigen receptor T (CAR T) cells from post-FIH through commercialization. The Sr. Process Engineer will lead a team of subject matter experts focused on enabling process improvements and automation of multiple integrated unit operations starting from cell isolation through expansion, gene editing, lentiviral transduction, and cryopreservation. The candidate will provide guidance on implementation of QbD principles in process development, establishing process control strategies, and process life cycle management. The candidate will lead a multidisciplinary group of up to 2 engineers and research associates to execute the development plan and support manufacturing campaigns. This role will collaborate closely with multiple cross-functional teams including Analytical Development, Research, Supply Chain and External Manufacturing to coordinate critical deliverables. The individual will also maintain a focus on innovation and process improvements to develop next generation allogeneic T cell manufacturing processes.

WHAT YOU’LL DO

• Serve as process SME for an allogeneic CAR T cell program
• Define life cycle management and establish process control strategies in close collaboration with CMC leads
• Lead and implement QbD principles to process development to identify robust operating regions within phase-approach pre-defined acceptance criteria per ICH guidelines
• Lead team to identify opportunities for process improvements including new bioprocess technologies and automation to enable commercial readiness
• Lead team in execution of the allogeneic CAR T cell therapy process development plan to ensure effective progression of CMC timelines
• Mentor, train, and motivate a group of engineers and research associates to plan, execute and analyze experiments
• Provide expert technical opinions to justify process development decisions
• Author, review, and approve technical documentation including reports, process descriptions, SOPs, and MBRs
• Support internal and external process transfers
• Draft and review technical sections to enable regulatory filings
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate the 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 Chemical, Biological or Biomedical Engineering plus 2 years of industry experience or equivalent. BA and/or MS plus 7+ yrs or equivalent combination of education and work experience.
• >2 year of progressive experience in cell therapy process development, preferably with clinical and commercial stage T cell therapy processes with focus on cell culture
• Proven ability to lead a team of junior engineers and research associates
• Experience designing and scaling key cell therapy unit operations, especially T cell cultures within bioreactors
• Strong track record of applying fundamental engineering and scientific principles to process design, modeling, and characterization
• Well versed with cGMP requirements and working in a regulated environment
• Advanced knowledge of immunology including T cell biology
• Excellent technical written and oral communication skills
• Effective collaborator with an agile mindset to thrive in a fast-paced, multi-site, team-oriented organizationPrior experience managing
• 1 direct report
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment