Director of Quality Assurance Cell Therapy« back

Nurix was founded by internationally recognized experts in the ubiquitin-proteasome (UPS) field and received its initial funding from leading life science investors Third Rock Ventures and The Column Group. Nurix recently entered into a multi-year collaboration with Gilead and Sanofi focused on developing bi-functional molecules to degrade protein targets as novel therapeutics. Additionally, Nurix has a strong internal drug discovery pipeline focused on oncology, immunology and inflammation. Nurix plans to advance two molecules into clinical trials in early 2021.

Position

We are seeking to hire a Director of Quality Assurance to oversee and manage all QA aspects of the production, control, and release of Adoptive T Cell therapy products during clinical development.

Key responsibilities:

  • Analyze and observe manufacturing processes; make recommendations to ensure compliance with cGMP regulations.
  • Develop QA policies, systems, and procedures applicable to the production of cellular therapies.
  • Review and approve manufacturing batch records, environmental monitoring, and laboratory QC data from in process and finished product testing.
  • Maintain batch, QC, and release documentation in compliance with cGMP
  • Provide QA oversight of CMOs
  • Be the primary contact during FDA/Regulatory Agency inspections; assures that any associated inspection/audit responses are timely and appropriate
  • Establishes strong partnerships with internal functional leads including CMC, Process Development, Regulatory

Required Qualifications

  • Advanced science degree
  • At least 8 years of relevant experience in QA in pharmaceutical industry with thorough understanding of requirements / regulations related to a cGMP environment
  • Deep knowledge of quality assurance as applicable to aseptic pharmaceutical manufacturing
  • Relevant experience across drug development, CMO relations, process validation, technology transfer, and QA release activities
  • Direct experience with aseptic adoptive T cell therapy manufacturing for human administration in pharmaceutical industry or academic setting.

Fit with Nurix Culture and Values

  • Strong team orientation; highly collaborative
  • Solutions and results-oriented focus
  • Hands-on approach; resourceful and open to diverse points of view

Application Process

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.

Apply Now