Director Quality Control Biochemistry

About the role

Sana Biotechnology manufacturing facility in Bothell, WA, is hiring new team members who believe in the potential of engineered cells as medicines, dedicated to quality, and passionate about delivering the possible to patients.

As a Director of Quality Control, Biochemistry, you will report to the Senior Director of Quality Control. This role is critical in establishing the Quality Control (QC) team, processes, and systems at the Sana Biotechnology site in Bothell to support the raw material, and product testing requirements. This role is required to be onsite in Bothell, WA.

What you'll do

• Provide technical, operational, and strategic leadership in the development and implementation of internal quality control business processes to support GMP raw material and product release and stability testing

• Oversee execution of laboratory instrument qualification, test method transfers and qualification activities for the QC laboratory

• Support establishment and maintenance of QC labs, including instrument/equipment calibration, preventative maintenance, and managing inventory supplies

• Provide technical support as a subject matter expert for Health Authority inspections and internal audits

• Provide support in authoring CMC sections of regulatory submissions

• Collaborate with peers within 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 collaborative facility startup environment

• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members

• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines

• Drive curiosity, grit, and resilience while executing against the current Good Manufacturing Practices across a performance driven environment

• Innate ability to assess talent that will help grow the organization and add to Sana's culture

What we're looking for

• BA or BS in life science or biochemistry degree

• 10+ years' experience in the pharmaceutical or biotechnology industry in a Quality Control, Analytical Development, Quality or Compliance function managing department teams

• 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, cell-based assays, PCR, and ELISA test methods)

• In-depth experience of QC analytical methods and regulatory/pharmacopeia requirements for biologic or cell/gene therapy product testing and method validation for US, EMA and ICH regulations and guidance documents

• In-depth experience in leading QC OOS and OOT investigations

• 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

• Successful facility laboratory startup and health authority inspection experience as a subject matter expert

• Experience with flow cytometry, bioassays, and molecular biological assays

• Cell and Gene Therapy product experience

• Experience facilitating continuous improvement initiatives

What you should know

• There may be potential exposure to BSL2 biohazardous materials that are handled in the laboratories

• There may be exposure to disinfectants that are used in cleanrooms and environmental microbial organisms from routine product and environmental testing

• The role is located in Bothell, WA at the Bothell manufacturing site

• The base pay range for this position at commencement of employment is expected to be between $190,000 to $230,000/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 for patients

• 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.