Scientist, Quality Control

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 are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Quality Control Scientist, you will report to the Senior Director of QC. You will perform a wide variety of test methods supporting Sanas cell therapy products while working with a cross-functional team on method development and transfer, creating sample plans and specifications, and overseeing CDMOs and contract test labs. This role is onsite in South San Francisco.

What youll do

• Perform routine release and stability testing using a variety of analytical methods, including flow cytometry, PCR, and cell-based assays.
• Document testing according to Good Documentation Practices and GMP data integrity requirements.
• Work cross-functionally with Analytical Development to design and execute studies supporting method development, transfer, and qualification.
• Work cross-functionally with Process Development, Quality Assurance, and other departments to optimize analytical testing, product specifications, and process control strategies.
• Coordinate technology transfer and QC activities at contract manufacturers and contract test labs
• Author and approve method qualification protocols and reports
• Own or contribute to change controls, investigations, and CAPAs
• Author specifications, test methods, sample plans, certificates of analysis, and stability reports
• Assist in developing quality systems, establishing SOPs, work instructions, and other procedures to support QC operations
• Manage laboratory equipment through installation, qualification, maintenance, and retirement

What were looking for

• S. plus 7 years or equivalent combination of education and work experience
• Hands-on experience with flow cytometry methods, including multi-color flow, panel design, and optimization of gating and data analysis
• Strong knowledge of GMP requirements and regulations
• Strong knowledge of GMP testing and quality systems
• Experience authoring and/or reviewing SOPs, test methods, and other quality-related documents
• Experience with change controls, deviations, and CAPAs
• Ability to work in a dynamic environment to deliver on-time project completion with tight timelines

What will separate you from the crowd

• Experience in flow cytometry method development and validation
• Experience with CytExpert and/or FCS Express flow cytometry software
• Experience with statistical software just as JMP
• Experience with additional cell therapy analytical methods such as ddPCR or cell-based bioassays
• Experience in raw material specifications and testing requirements
• Experience managing contract manufacturing organizations or contract testing laboratories
• Experience implementing rapid test methods (e.g. BACT/ALERT) in place of conventional methods

What you should know

• There may be potential exposure to BSL2 and BSL2+ biohazard materials
• Travel may be required
• Occasional off-hours or weekend work may be required
• Physical Demands: Employees in this position may be required to perform the following physical activities: standing, walking, and sitting for extended periods of time; frequent use of the hands, fingers, wrist, and greater arm to handle small materials, tools, boxes, and trays; lifting and carrying objects up to 10 Ibs; occasional overhead reaches and lifts; occasional lifts and reaches below the knee; occasional pushing and pulling of materials and objects with moderate forces; occasional crouching/kneeling, twisting, and squatting movements.
• Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job.
• The base pay range for this position at commencement of employment is expected to be between $145,000 and $175,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

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. 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 Sanas 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.