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 an External Quality Control Principal Research Associate, you will report to the Senior Director, Analytical Development and Quality Control. You will support a wide variety of analytical methods for Sana’s cell therapy products while working with a cross-functional team on method development, transfer, and qualification, providing onsite training and technical support at CDMO, and overseeing contract test labs to enable drug product release. This role is onsite in South San Francisco, CA.
What you’ll do
- Collaborate with the Analytical Transfer Lead to transfer release methods to contract development and manufacturing organization (CDMO) and provide onsite training and technical support to enable GMP implementation
- Assist with the coordination of QC activities at CDMO and contract test labs (CTLs), including providing technical guidance on troubleshooting and participating in data review
- Work with method developers and external partners to design and execute studies supporting method development, transfer, and qualification
- Perform routine release, characterization, and stability testing and document testing according to Good Documentation Practices and GMP data integrity requirements as appropriate
- Work cross-functionally with Process Development, MSAT, Quality Assurance, and other departments to optimize sampling plan, analytical testing, product specifications, and process control strategies
- Author, review, and approve method qualification protocols and reports
- Own or contribute to change controls, investigations, and CAPAs
- Support the authoring and maintenance of product specifications, test methods, sampling plans, certificates of analysis, and stability study reports
- Assist in developing quality systems, establishing SOPs, work instructions, and other procedures to support QC operations
- Manage laboratory equipment and software through installation, qualification, maintenance, and retirement
What we’re looking for
- S. or M.S. in Cell Biology, Immunology, or a related scientific discipline with 5-6 years related work experience
- Experience developing, optimizing, and qualifying multi-color flow cytometry methods according to ICH guidelines and performing data analysis independently with minimal guidance
- Experience transferring analytical methods to CDMOs CTLs and overseeing GMP implementation
- Experience authoring and/or reviewing SOPs, test methods, and other quality-related documents
- Strong knowledge of GMP requirements and regulations
- Strong knowledge of GMP testing and quality systems
- 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 supporting the rapid release of cell therapy products in a GMP environment
- Experience implementing rapid safety test methods (e.g. BACT/ALERT for sterility and BIOFIRE for mycoplasma) in place of conventional methods
- Experience using statistical software such as JMP for DOE, data visualization, and analysis
What you should know
- Travel to CDMO to provide onsite training and technical support is required
- There may be potential exposure to BSL2 and BSL2+ biohazard materials
- 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 $115,000 - $145,000 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 workforce with varied backgrounds 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 a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample 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.
Top Skills
What We Do
Sana Biotechnology is focused on utilizing engineered cells as medicines for patients. The ability to modify genes and use cells as medicines will be one of the most important advances in healthcare over the next several decades. Sana is building differentiated capabilities across the spectrum of cell and gene therapy. Three aspirations drive Sana as we look to discover treatments for patients with poor outcomes or currently untreatable diseases. The first is the ability to repair and control the genes in any cell in the body. We are advancing novel delivery technologies with the goal of being able to deliver any payload to any cell in a specific, predictable, and repeatable manner, paving the way for next-generation in vivo gene therapy. Next is the ability to differentiate pluripotent stem cells ex vivo into immune-cloaked functional cells with the aspiration of being able to replace any missing or damaged cells in the body. Last is a belief we can enable broader access to our therapies through focusing on scalable manufacturing solutions, the cost of manufacturing, and aligning with key stakeholders. Sana launched in early 2019 and has over 350 employees in Seattle, Cambridge, and South San Francisco. Sana was founded with the long view – bringing together great people and the best technologies to deliver on the challenging promise of using engineered cells to meaningfully change the outcome of many human diseases.
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