- Serve as technical person-in-plant at the contract manufacturing site providing on the floor technical support to drive manufacturing excellence
- Collect and analyze manufacturing data to identify areas for improvement
- Support investigations, participate in root cause analyses, and recommend appropriate corrective actions
- Participate in technology transfers and support implementation of operational improvements for manufacturing processes
- Support training of manufacturing personnel to implement new processes and procedures
- Draft technical documents including master batch records and components of technology transfer packages
- Function as a manufacturing subject matter expert within the MSAT organization
- Bachelor's in Chemical, Biological or Biomedical Engineering plus 4 yrs or MSc plus 1-2 yrs or equivalent combination of education and work experience
- > 2 years of experience in biologics, viral vector, or cell therapy manufacturing
- Detail-oriented with good problem-solving, technical writing and verbal communication skills
- Excellent technical written and oral communication skills
- Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
- Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
- A team player who's highly organized with excellent communication skills, demonstrates curiosity and scientific rigor and excellent problem-solving skills
- Experience with cell therapy manufacturing processes and equipment including T cell isolation, lentiviral transduction, gene editing, expansion in bioreactors, cell harvest, and cryopreservation
- Well versed with cGMP requirements and working in a regulated environment
- Prior experience supporting tech transfers to external partners
- Working knowledge of statistical Design of Experiments (DoE)
- Knowledge of R, Python, JMP, Spotfire
- Travel up to 50% of the time
- Work in a grade B space, including sterile gowning
- Some weekend work
- This position requires handling of healthy donor human blood products
- The base pay range for this position at commencement of employment is expected to be between $100,000 and $120,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
- 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
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Cell Therapy Process Engineer I - 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. As a Cell Therapy Process Engineer I (MSAT) you will report to the Sr. Engineer, MSAT to support clinical manufacturing of Sana's multiple allogeneic chimeric antigen receptor (CAR) T cell programs. As the technical person-in-plant, you will provide on the floor support at the contract manufacturing site and technical oversight to drive manufacturing excellence. You will work on internal and external project teams to support technology transfers, manufacturing investigations, and train manufacturing staff. You will develop process trending tools, provide process improvement recommendations, and play a key role in the lifecycle of Sana's products.
What you'll do
What we're looking for
What will separate you from the crowd
What you should know
How we work together for patients
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'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.
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.