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Senior Engineer, Cell Therapy Process Development - Seattle, United States - Sana Biotechnology, Inc.
Description
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.
Director of Cell Therapy Process Development and drive the development of a novel allogeneic chimeric antigen receptor T (CAR T) cell manufacturing process.
The Sr.Process Engineer will serve as the process subject matter expert, lead development, and coordinate the integration of multiple unit operations including cell isolation and expansion, gene editing, lentiviral transduction, and cryopreservation.
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 doServe as process SME for an allogeneic CAR T cell program
Define process development strategy in close collaboration with the CMC and Process Leads.
Lead the execution of the allogeneic CAR T cell therapy process development plan
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
Draft, review, and approve technical documentation including reports, process descriptions, SOPs, and MBRs
Support internal and external process transfers
Draft technical sections to support regulatory filings
Evaluate new bioprocess technologies and implement process advancements for introduction into a GMP manufacturing environment
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
Working knowledge of statistical design of experiments (DoE)
Excellent technical written and oral communication skills
Effective collaborator with an agile mindset to thrive in a fast-paced, multi-site, team-oriented organization
Prior experience managing ≥1 direct report
Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
What will separate you from the crowd
Experience with T cell isolation, lentiviral transduction, gene editing, cell harvest and cryopreservation unit operations design and scaling
Well versed with current cell therapy manufacturing platforms
Experience selecting raw materials and equipment suitable for cell therapy processes
Familiarity applying PAT to cell therapy
Proficient with relevant analytical methods including flow cytometry and cell-based assays
Knowledge designing high throughput T cell culture scale down models
Familiar with R, Python, JMP and FlowJo software
Demonstrate intense technical curiosity and a continuous drive to learn new skills
What you should know
The base pay range for this position at commencement of employment is expected to be between $140,000 and $160,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
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
How we work together for patients
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.
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'sBenefits 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.
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