The successful candidate will be a key contributor within CMC (Chemistry, Manufacturing and Control) and support the advancement of small molecule programs within the Nurix development portfolio.
In this newly-created position, the candidate will be responsible for providing hands-on support of development stage activities related to the analysis, quality control and stability testing of drug substances (DS) and drug products (DP). Reporting to the Head of CMC, candidate will also be responsible for building and growing an Analytical Development group.
Responsibilities:
- Coordinate the outsourced testing and quality control activities at CDMOs for drug substances and drug products of small molecule therapeutics.
- Manage development and validation of robust and sensitive methods for DS and DP
- Manage the identification and characterization of impurities
- Oversee transfer of analytical methods between testing laboratories and CDMOs.
- Review primary analytical data and method development reports.
- Develop method validation protocols, oversee their execution and review the reports.
- Work with DS and DP project leads to establish phase-appropriate specifications, and ensure that testing methodologies are suitable and meet the cGMP requirements.
- Manage external stability testing of DS and DP to ensure that the data support ongoing and proposed clinical studies.
- Manage supplies of reference standards, including coordinating qualification and retest
- Proactively identify gaps in analytical testing and risks and identify solutions to mitigate these risks.
- Author analytical development sections of regulatory filings.
- Work closely with stakeholders across various functional groups to successfully implement activities to advance programs in a timely manner
- Represent CMC Department in project teams and make periodic presentations to program oversight committees.
- Performs other duties as assigned
Qualifications:
- Ph.D. or Master’s degree in analytical chemistry, organic chemistry or related discipline with
- A minimum of 12 years’ experience in small-molecule analytical development
- Experience in all phases of drug development, pre-clinical to late-phase and commercial, preferably in small-pharma/biotech environment
- At least 5 years’ experience in managing outsourced testing of DS and DP
- Familiarity with operating in a GMP environment, and a thorough knowledge of FDA, ICH, USP and EP Guidelines and current best-practices in the Industry
- Hands on experience authoring CMC sections of regulatory filings (IND, IMPD, NDA)
- Excellent communication skills
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.
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