Director, Quality Control

About the role

Sana Biotechnology is looking to expand our team with individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to implement that vision.

We are looking for someone to help with the establishment the Quality Control (QC) function at Sana Biotechnology. You will join an innovated, diverse team in charge of analytical development and quality control responsibilities to support the advancement of Sana's pipeline. This position 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

• Provide technical, operational, and strategic leadership in the development and implementation of internal and external quality control business processes and related activities
• Management and leadership of external QC contract organizations
  • Select, oversee and manage QC contract organization and laboratories. This includes technical/operation due diligences, routine performance, audits and method lifecycle management
  • Evaluate and review control strategies for raw material, in-process, release, and stability testing
  • Write, review, and approve SOPs, method qualification, validation, transfer protocols/reports and lifecycle management activities
  • Coordinate activities between Sana and contract laboratory service providers
  • Resolve discrepancies with contract organizations and laboratories
  • Partner in investigations to drive timely resolution of issues
• 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 (ex-vivo and in-vivo products), allogeneic cell therapy products, stem-cell derived products
• Create Sana’s raw material safety risk assessments and material specifications
• Manage method optimization, transfer, qualification or validation activities for Sana QC laboratories
• Manage internal QC testing of raw materials, in-process and finished product samples, environmental monitoring and microbiology, stability testing, instrument and software qualification, and QC data integrity
• Support internal and contract organization as a QC Subject Matter Expert for analytical methods, sampling, troubleshooting, investigations
• Support establishment and maintenance of QC labs (lab organization, instrument/equipment calibration, preventative maintenance, purchase; lab cleaning, etc)
• Provide technical support for manufacturing site and product related inspections (e.g. periodic cGMP inspections)
• Provide support for CMC sections of regulatory submissions
• 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
• Support a creative startup environment

What we're looking for

• Ph.D. Degree in Biochemistry, Analytical Chemistry, or a related field with at least 8 years of relevant experience in the biotechnology or pharma industry with a primary focus on analytical QC for cell therapy/gene therapy/biologic products are preferred. An expert in QC. B.S./M.S. degrees with equivalent combination of education and experience also considered
• 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 ELISA test methods) and/or microbiological methods (e.g. bioburden, sterility, endotoxin) in addition to other methods
• In-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic or cell/gene therapy product testing and method validation
• In-depth experience in leading internal and external QC investigations
• Familiar with change control, LIMS, discrepancy/CAPA owner
• Use of Laboratory 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.)
• Ability to effectively prioritize and deliver high-quality results on tight timelines
• Excellent written, verbal communication and presentation skills

What will separate you from the crowd

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

What you should know

• 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

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, 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.

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.