Associate DirectorDirector Pharmaceutical Development
Associate DirectorDirector Pharmaceutical Development
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Job Description
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 Nurixs extensive expertise in E3 ligases together with its proprietary DNAencoded 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. Nurixs 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.
Nurixs wholly owned pipeline comprises targeted protein degraders of Brutons tyrosine kinase a Bcell signaling protein and inhibitors of Casitas Blineage lymphoma protooncogeneB an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco California.
Position Description
Nurix is looking for an Associate Director/Director of Pharmaceutical Development to provide scientific technical and handson leadership of clinical product manufacturing through commercial launch of smallmolecule oral solid drug products. This individual will oversee oral solid drug product process development technology transfer 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 Nurixs Executive Director of Pharmaceutical Development.
Responsibilities will include:
- 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 PersonInPlant 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 12 years) of industrial latephase smallmolecule 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
- Experience with lipid formulation development and manufacturing would be a plus
- Experience with topical formulation and/or transdermal drug delivery system development and manufacturing would also be a plus
- Extensive thirdparty 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
- Indepth 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 problemsolving abilities
- Ability to multitask manage conflict and work in a fastpaced environment
- Ability to travel up to 25 of time
Fit with Nurix Culture and Values
- Strong team orientation highly collaborative
- Solutions and resultsoriented focus
- Handson 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.
Nurix Therapeutics Inc. is committed to protecting and respecting your privacy and personal information including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix you agree to our collection and use of personal information as described in our Privacy Policy Experience:
Director
Employment Type
Full Time
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