Sana Biotechnology, Inc. · 1 day ago
External Quality Control Principal Research Associate
South San Francisco, CA
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $145K/yr
5+ years expSana Biotechnology is growing, and they are hiring new team members who believe in the potential of engineered cells as medicines. As an External Quality Control Principal Research Associate, 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.
BiotechnologyHealth CareLife ScienceProduct Research
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
Employee health coverage
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
A variety of wellness offerings to support each person individually
Company
Sana Biotechnology, Inc.
Sana Biotechnology is focused on utilizing engineered cells as medicines for patients.
201-500 employees
H1B Sponsorship
Sana Biotechnology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (15)
2023 (8)
2022 (24)
2021 (8)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
$951.3M2025-08-06Post Ipo Equity· $86.3M
2024-02-07Post Ipo Equity· $165M
2021-02-04IPO
Leadership Team
Steve Harr
President and Chief Executive Officer
Richard Mulligan
Vice Chairman and Head, Sana X
Recent News
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-12-10
2025-12-09
Company data provided by crunchbase