Senior Scientist, Quality Control

About the role

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

We are looking for a qualified individual to assist in the establishment the Quality Control function at Sana Biotechnology. You will join an innovated, multi-disciplinary team in charge of analytical development and quality control responsibilities to support the advancement of Sana's pipeline. You will report to the Head of Quality Control and work cross-functionally with colleagues within Research, Technical Operations, Clinical Development and Program Management.

What you'll do

• Participate in the writing and review of Quality Control SOPs, method validation and verification protocols and reports as needed
• Raw material safety review and establishment of material specifications
• Participate in method optimization, method qualification or validation activities for in-house testing and equipment
• Perform testing and/or review of QC tests for in-house testing and CTDMO tests which could include raw materials testing, in-process and finished product testing, environmental monitoring and microbiology, stability testing, instrument and software qualification, and QC data integrity
• Support Certificate of Analysis (product specifications) 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
• Support in-house teams and CTDMO teams as a QC SME for analytical methods, sampling, troubleshooting, investigations
• Support establishment and maintenance of QC labs (e.g. lab organization, instrument/equipment calibration, preventative maintenance, purchase; lab cleaning, etc.)
• Lead activities associated with validation and transfer of QC Methods used to support raw material, in-process, lot release and stability testing programs including CTDMOs and strategic partners
• Provide technical support for manufacturing site and product related inspections (e.g. periodic cGMP inspections)
• Work collaboratively with other functions in Analytical Development in the establishment of Control Strategies for Sana products
• Provide support for CMC sections of regulatory submissions
• Work with other Tech Ops stakeholders in process development, quality and regulatory to support establishment of control systems, set appropriate product specifications, develop comparability strategies, and support manufacturing investigations
• Support an innovative startup environment

What we're looking for

• Ph.D. in Biochemistry, Analytical Chemistry, or a related field with at least 5 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 OR a subject matter expert in QC with the following:
  • MS Degree and 8+yrs experience,
  • BS Degree and 10+yrs experience
• The ideal candidate for this position 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
• Prior experience with authoring of Quality owned regulatory filing sections (e.g. JOS, method summaries, etc.) a plus
• 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

• 10-20% travel may be required
• Lab work required at both lab bench and biosafety cabinet
• Some lifting of consumables required
• Working safely on a predictable and regular basis is an essential job function for this position and the Company requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19

#LI-DNI

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. We cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, 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, 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.