Scientist I/Scientist II, Process Chemistry, Chemical Development

Location
San Francisco, CA, United States
Posted
Jun 05, 2021
Ref
5310442002
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Summary

The Scientist I/Scientist II Process Chemistry, reporting to the Director of Chemical Development, CMC, will be responsible for executing in-house process chemistry efforts at Nurix as well as manage process chemistry and GMP manufacturing efforts at contract manufacturing organizations and partner facilities. This individual will work with Medicinal Chemistry to evaluate synthetic routes for late stage discovery projects to facilitate smooth scale up for supply of compounds for pre-clinical and clinical studies. He/she will also work closely with Formulation and Analytical Development to define key attributes of our molecules and GMP manufacturing processes (e.g. solid forms, specifications, IPCs, stability, etc.) and with Supply Chain to help deliver clinical supplies for all programs at Nurix. The ideal candidate will have solid understanding of Organic Chemistry, Manufacturing, Analytical Development, CMC Regulatory and Quality Assurance.

Job Responsibilities

Essential duties and responsibilities include but are not limited to the following:
  • Execute in-house process development and optimization studies to facilitate scale-up and transfer to CMOs
  • Manage process chemistry work at CMOs from initiating process transfer, through scale up, GMP manufacturing and process validation activities
  • Prepare technical packages for transfer of processes to CMO or partner facilities
  • Work with discovery teams to evaluate synthetic routes and test alternatives that facilitate scale up of both target compounds and building blocks while providing insights for selection of development candidates
  • Work with Formulation Development and Analytical Chemistry to understand and characterize the physical and chemical properties of compounds of interest
  • Provide technical support to QA for vendor qualification and auditing
  • Technical review and approval of master batch records and executed batch records
  • Partner with Manufacturing, Formulation Development, Analytical Chemistry, Quality Control and Quality Assurance to ensure drug substances are delivered on time and within specification
  • Write and review CMC sections of regulatory filings when needed

Required Qualifications
  • A Ph.D. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field with at least 2 years (M.S. with 8 years or B.S. with 10 years) of relevant experience in the biotech/pharmaceutical industry
  • A demonstrated track record of delivering results with high integrity, quality focus and collaboration
  • Expert knowledge of process chemistry, synthetic organic chemistry, analytical methods (especially NMR, MS and HPLC) and physical-chemical characterization of compounds
  • Experience in a GMP environment and working knowledge of FDA and ICH Guidelines
  • Proven ability to develop, optimize and scale up drug substance manufacturing processes
  • Demonstrated skills needed to manage GMP contract manufacturing organizations
  • Excellent interpersonal skills, including clear, succinct and timely communication and ability to foster important relationships with customers and key stakeholders
  • Excellent oral and written communications skills
  • Excellent organizational skills, with ability to successfully manage multiple priorities
  • Ability to work effectively with cross-functional teams
  • Highly self-motivated and detail-oriented, with ability to work independently

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.