Director of Quality Assurance Cell Therapy
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.
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.
- 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
- 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
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.