Senior Operations 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 want to challenge status quo, and who lead with the desire to work on novel ideas. As a Sr. Operations Scientist, Quality Control, you will report to Head of Corporate Quality Control, and will help build out the corporate QC function, support assay transfer and qualification activities, and support the raw materials qualification program.
What you’ll do
- Serve as the QC Subject Matter Expert (SME) for compendial requirements, raw materials testing, analytical methods, sampling, stability, and investigations to support Sana’s cell therapy programs
- Support material qualification program including raw materials risk assessments
- Partner with Analytical Development to ensure analytical methods are successfully transferred to QC
- Manage method optimization, transfer, qualification, or validation activities for Sana QC laboratories
- Establish QC business process and procedures including product specification generation for batch release of Sana’s critical raw materials and drug products
- Support the QC laboratory and GMP testing readiness
- Support deviations, OOS, change control, investigations, and CAPAs
- Support the review and authoring of regulatory filing activities
- Collaborate with other Tech Ops partners in analytical, process development, quality and regulatory to support establishment of control systems, set appropriate product specifications, develop comparability strategies, and support manufacturing investigations
- Collaborate with Manufacturing, QA, and Process Development teams to evaluate and investigate issues
What we’re looking for
- PhD in Cell Biology, Molecular Biology, Immunology, or a related scientific discipline w 5+ yrs experience in academic research and/or industry. BA or MS plus 8+ yrs or equivalent combination of education and work experience
- Deep subject matter expertise in Quality Control. You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings
- Experience managing a raw material qualification program
- Experience in performing phase-appropriate assay qualification/validation in a GLP or GMP environment
- Experience in transferring assays from internal AD to QC teams and externally to a CDMO
- Knowledge and understanding of regulatory guidelines from the FDA, ICH, USP, EP, etc.
- Excellent written and oral communication skills
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.
- Goal oriented with the ability to troubleshoot and resolve problems
- Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization
- High degree of self-motivation
What will separate you from the crowd
- Experience at a startup or pre-clinical biotechnology company; cell or gene therapy experience is a plus.
- Technical expertise in any of the following areas: multi-color flow cytometry assays, cell-based assays for potency, viral titer assays, or molecular assays utilizing ddPCR and/or qPCR
What you should know
- Up to 10% travel is required
- Working in BSL-2 and BSL-2+ labs is required
- Occasional weekend work is required
- The base pay range for this position at commencement of employment is expected to be between $150,000 and $180,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together
- 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 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.