• 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