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Associate Director, Quality Operations (Bothell)

Sana Biotechnology

Sana Biotechnology

Operations, Quality Assurance
Bothell, WA, USA
Posted on Wednesday, May 22, 2024

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 the Associate Director of Quality Operations, you will report to the Executive Director of Quality at the Bothell site. This role is critical in providing Quality oversight for establishing procedures at the startup of the Bothell manufacturing facility and ultimately ensuring successful execution and maintenance of the established process and procedures. This role supports Manufacturing, Laboratory and Warehouse Operations and is required to be onsite in Bothell, WA.

What you'll do

  • Provide leadership for Quality oversight for the facility start-up, including support for the establishment of Manufacturing, Laboratory and Warehouse operations
  • Establish process and procedures for batch record review
  • Support risk management activities and approve risk management reports
  • Serve as a subject matter expert for Health Authority inspections and internal audits
  • Establish and execute material and product disposition activities, in compliance with US and EU requirements
  • Support new product introduction activities, including Quality oversight of tech transfer
  • Collaborate with global Quality Validation to support oversight of facilities and engineering related processes for equipment, facilities and utilities, post qualification.
  • Post facility qualification will also require:
    • Quality oversight activities for deviations, CAPAs and change controls
    • Managing and assessment vendor-initiated changes impacting the site
  • Manage performance and development of direct reports

What we're looking for

  • BA or BS in life science degree
  • 8+ years of experience in the pharmaceutical or biotechnology industry in Quality Assurance or Quality Systems or equivalent combination of education and work experience
  • Demonstrated experience in Quality Operations functions within a GMP facility of cell/gene therapy products or biologics in both clinical and/or commercial settings
  • Previous experience in Quality Operations, in start up or operational setting
  • Ability to effectively prioritize and deliver high-quality results on tight timelines.
  • Extensive knowledge of cGMPs
  • Excellent written, verbal communication and presentation skills
  • Resilient leader and willing to collaborate across cross functional teams

What will separate you from the crowd

  • Previous experience working in facility start up projects, and maturation of systems
  • Previous experience interacting with Health Authority investigators
  • Cell and Gene Therapy product experience
  • Experience working in both electronic and manual systems

What you should know

  • The role is located in Bothell, WA at the Bothell manufacturing site
  • May need to successfully pass and maintain aseptic gowning qualifications. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots
  • Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the job
  • The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/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.