Company
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell.
Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.
Position Description
Nurix is looking for a Director of Pharmaceutical Development to provide scientific, technical, and hands-on leadership of clinical product manufacturing through commercial launch of small-molecule oral solid drug products. This individual will lead internal drug product manufacturing process development efforts and oversee drug product development and manufacturing activities at CMOs. The ideal candidate is highly motivated and able to work in a dynamic entrepreneurial environment with broad responsibilities and opportunities. The position reports to Nurix’s Executive Director of Pharmaceutical Development.Responsibilities will include:
- Lead in-house drug product manufacturing process development and optimization studies to facilitate process transfer to CMOs and scale-up.
- Oversee technical activities at drug product CMOs including tech transfer, CTM production, process troubleshooting, QBD and PAR studies, registration batch production and process validation.
- Coordinate with CMOs, Nurix QA and Nurix Global Supply Chain to ensure timely manufacture and release of DP lots by leading technical reviews of drug product master and executed batch records, deviations, change controls, nonconformance investigations, etc. and proactively identify/mitigate risks related to CTM supply.
- Partner with Nurix Chemical Development and Analytical Development to identify optimal drug substance properties and control strategies.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Nurix policies and procedures.
- Provide Person-In-Plant support for drug product manufacturing.
- Serve as drug product SME for internal program teams and due diligence activities as well as CMO selection, management and audits.
- Write and review CMC sections of regulatory filings including INDs, IND amendments and NDA/BLAs.
- Coordinate with Nurix Analytical team to ensure that expiry and retest dating is current and fully aligned with drug product supply plan.
- Contribute to internal and external presentations and publications.
- Manage and provide technical mentorship of scientists and engineers.
Required Qualifications
- Ph.D. in chemistry, pharmaceutical sciences, engineering or related field with at least 8 years (M.S. with 14 years or B.S. with 16 years) of industrial late-phase, small-molecule drug product development experience
- Extensive knowledge/experience in GMP oral solid dose form manufacturing (spray drying, hot melt extrusion, tableting and encapsulation), characterization, process development, scale up and process validation
- Extensive third-party drug product CMO management experience including tech transfer activities, QBD studies, clinical supply production, registration batch production and commercial launch activities
- Knowledge and understanding of product/packaging interactions, barrier properties, stability, global pharmaceutical packaging regulations and package testing
- In-depth knowledge of relevant cGMP, ICH, FDA and EMA guidelines
- Proven track record of effective internal and external collaboration
- Excellent oral/written communication skills, interpersonal skills and problem-solving abilities
- Ability to multi-task, manage conflict and work in a fast-paced environment
- Ability to travel up to 25% of time
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.
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