Senior Scientist, Chemical Development
PharmaBiotechCROClinical ResearchRegulatory AffairsQuality Assurancegmpcdmregulatory submissioncrorave
Job description
Senior Scientist, Chemical Development
Help move Nurix’s portfolio from the bench to the clinic. As a Senior Scientist in Chemical Development, you’ll scout routes, build scalable processes, and work with CROs/CDMOs to supply drug substance for early clinical trials, spending up to half your time hands-on in the lab. It’s a role with broad responsibilities and real opportunity in a small, entrepreneurial environment. Position Description
The Opportunity Own chemical development activities across the portfolio, including process development and manufacture of regulatory starting materials (RSMs) and supporting production of Drug Substance (DS) for clinical trial materials, with a focus on the early development space
Route scouting of pre-clinical and clinical candidates
Support the pre-clinical research team by developing robust and scalable processes to support initial scale-up for animal studies
Work up to 50% of the time in the lab to support early route scouting and discovery scale-up efforts toward CMC transition
Author tech transfer documents and work with CROs/CDMOs to effectively and efficiently reproduce chemistry at various sites
Support RSM and DS manufacturing activities at CRO/CDMO sites, including scale-up of candidate compounds to support candidate selection during drug discovery
Support phase-appropriate process characterization, identify critical quality attributes, and implement controls, including selection and justification of RSMs, to ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards and to ensure consistency of DS quality
Prepare and/or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions
Travel up to 10% What You’ll Bring A highly motivated chemist with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities
PhD with 2-7 years of experience or MS with 5+ years of experience; advanced degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
2-5 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment preferred
Experience leveraging US and International CRO/CMOs for the manufacture of RSMs and DS to meet aggressive timelines
Strong working knowledge of synthetic organic chemistry and the ability to leverage it toward route development and rapid synthetic triage
Experience with payload linker development for ADC is a plus
Experience analyzing experimental and analytical data
Able to identify and resolve critical issues
Experience implementing technical, strategic, and operational plans
Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
Strongly team oriented Location: Onsite – Brisbane, CA 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 About Nurix Therapeutics
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
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