Senior 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.  We are looking for someone to help with the establishment the Quality Control (QC) function at Sana Biotechnology. As Senior Operations Scientist, Quality Control, you will join an innovated, diverse team in charge of analytical development and quality control responsibilities to support the advancement of Sana's pipeline. You will work with colleagues within Research, Technical Operations, Clinical Development and Program Management and report to the Senior Director, Quality Control.

What you'll do

• Be the QC Subject Matter Expert for Quality Control (SME for compendial requirements, analytical methods, sampling, stability, troubleshooting, investigations) supporting our vast pipeline
• Provide technical support for manufacturing site and product related inspections (e.g. periodic cGMP inspections)
• Provide support for CMC sections of regulatory submissions
• Manage method optimization, transfer, qualification, or validation activities for Sana QC laboratories
• Help develop phase-appropriate quality control capabilities, business process and procedures including product specification (Certificate of Analysis) generation for batch release for e.g. MCB, plasmids, viral vectors, allogeneic cell therapy products, stem-cell derived products
• Support the QC laboratory and GMP testing readiness
• Work 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

What we're looking for

• PhD in 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 and an emerging leader. 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
• Experienced with analytical test methods used for cell/gene therapy (e.g. flow cytometry, PCR) and/or microbiological methods in addition to other methods
• Experience with regulatory/pharmacopeia requirements for biologic or cell/gene therapy product testing and method validation
• Experienced in leading internal and external QC investigations
• Familiar with change control, LIMS, discrepancy/CAPA owner and use of lab computer systems and GMP Quality Systems such as: TrackWise, LIMS, DMS, LMS
• Prior experience with authoring of Quality owned regulatory filing sections (e.g. JOS, method summaries, etc.)
• Excellent written, verbal communication and presentation skills

What will separate you from the crowd

• Experience drafting regulatory submissions (e.g. IND/CTAs, IND amendments, BLA, etc.)
• Excellent ability to work collaboratively in a complex, matrix, fast-paced environment
• Ability to effectively prioritize and deliver high-quality results on tight timelines
• Demonstrated ability to independently problem solve including the ability to create and implement practical solutions to resolve QC issues

What you should know

• Some travel will be required
• Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC
• The base pay range for this position at commencement of employment is expected to be between $155,000 and $175,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
• 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.  Details of participation in these benefit plans will be provided if a candidate receives an offer of employment

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.

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.