Senior Director, Quality Control - Seattle, WA, United States - Sana Biotechnology

Description

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and lead with the desire to work on novel ideas. As the Bothell Sr. Director Quality Control, you will report to the Executive Director, Site Quality Head, Technical Operations, to provide the Quality Control oversight on the facility startup, qualification and validation activities, and the routine analytical product and in-process controls at the site.

What you'll do

• Provide Quality Control oversight for the facility startup, including qualification and validation activities
• Build GMP quality systems and the compliance infrastructure for the Quality Control labs
• Oversee lab instrument qualifications and test method transfers and qualifications
• Establish and maintain analytical assay performance trending program and reference standard trending program. Approve reports as per schedule
• Oversee management of product and materials stability programs
• Establish test reagent and materials inventory management process to ensure testing execution to planned schedules
• Oversee equipment and instrument maintenance and calibration program to ensure testing execution to planned schedules
• Manage the critical utilities monitoring program for the production facility and labs
• Oversee material qualification program including materials risk assessments
• Lead inspections by FDA, or other regulatory agencies for Quality Control topics
• Serve as Business Process Owner for LIMS implementation
• Manage to a high level of efficiency in lab execution by adopting strong interdepartmental communications and lean labs processes.
• Manage and mentor staff to ensure a high performing team
• 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, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

What we're looking for

• Familiarity with the US, EMA, and ICH regulations and guidance documents and USP, EP and JP
• Good working knowledge of analytical and bioanalytical assays
• Demonstrated ability to engage team members across diverse teams
• Promote curiosity, scientific rigor, and excellent problem-solving skills
• Experience implementing Quality/Compliance systems
• Collaboration skills
• Experience with Project Management and Analytics software
• BA or BS in life science or biochemistry degree
• 12+ years' experience in the pharmaceutical or biotechnology industry in a Quality Control, Analytical Development, Quality or Compliance function managing department teams

What will separate you from the crowd

• Cell and Gene Therapy product experience
• Successful facility startup and regulatory inspection experience
• Experience with flow cytometry, bioassays, molecular biological assays and microbiological assays

What you should know

• Work may involve aseptic gowning for activities in the cleanroom
• 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 will be located in Seattle, WA until the Bothell manufacturing site is ready for occupancy
• The base pay range for this position at commencement of employment is expected to be between $230,000 and $270,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience