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Director Quality Control Microbiology

Sana Biotechnology

Sana Biotechnology

Administration, Quality Assurance
Bothell, WA, USA
Posted on Thursday, November 9, 2023

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 Director QC Microbiology, you will report to the Executive Director, Site Quality Head, Technical Operations, to provide the QC Microbiology oversight on the facility startup, qualification and validation activities, and the routine microbiological controls and aseptic operations at the site.

What you’ll do

  • Provide QC Microbiology oversight for the facility startup, including qualification and validation activities
  • Build GMP quality systems and the compliance infrastructure for the QC Microbiology labs
  • Manage the Environmental Monitoring program and Aseptic Gowning Qualification program for the production facility
  • Establish and maintain the Microbiological and EM trending results program and approve reports as per schedule
  • Lead the microbiological risk analyses of facility and processes that drive the microbiological monitoring strategy and program
  • Contribute to aseptic process designs and aseptic operator training and qualification program and aseptic process simulation program.
  • Manage the microbiological methods development, qualifications and verifications
  • Coordinate execution of disinfection effectiveness studies
  • 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
  • Lead inspections by FDA, or other regulatory agencies for microbiological control topics
  • 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
  • Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

  • Familiarity with the US, EMA, and ICH regulations and guidance documents including aseptic guidance such as Annex 1, USP, EP and JP
  • Good working knowledge of microbiological assays
  • Good working knowledge of cleanroom design and operations, and aseptic processing
  • 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 Microbiology, life science or biochemistry degree
  • 10+ years of experience in the pharmaceutical or biotechnology industry in a Microbiology, 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
  • Management of cleanroom and aseptic processing controls including aseptic fill operations

What you should know

  • Work may involve aseptic gowning for activities in the cleanroom
  • 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 $190,000 and $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

  • 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.