Chemical Development Director/Assoc. Director

Location
San Francisco, CA, United States
Posted
Jan 29, 2021
Ref
5056169002
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Job Summary:

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 process development, synthesis and manufacturing of Nurix clinical candidates. Reporting to the Head of CMC, candidate may also be responsible for building and growing the Chemical Development group.

Responsibilities:

 

  • Develop practical and scalable synthesis routes, both internally and at CDMOs, for the manufacture of small molecule drug substances.
  • Manage development of robust phase-appropriate syntheses for starting materials and intermediates
  • Identify, select and manage CDMOs for process development, optimization and manufacture of cGMP DS to support clinical programs
  • Oversee transfer of processes to, and between CDMOs.
  • Review manufacturing records (MBR, EBR etc) and development reports.
  • Prepare technical reports, publications and presentations
  • Work closely with DP project leads to establish realistic project timelines and deliver adequate quantities of DS for development needs
  • Proactively identify potential gaps in drug supply, related risks and identify solutions to mitigate these risks.
  • Author DS 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 organic chemistry, chemical engineering or related discipline with
  • A minimum of 12 years' experience in small-molecule chemical 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 CDMOs in outsourced development and manufacturing
  • Familiarity with operating in a GMP environment, and a thorough knowledge of FDA, ICH 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.