Senior Scientist, Chemical Development
About The Position
The Senior Scientist, Chemical Development will lead chemical development activities across Nurix’s portfolio, with a focus on early development. The role includes route scouting for preclinical and clinical candidates, process development and manufacture of regulatory starting materials (RSMs), and support for drug substance (DS) production for clinical trial materials. The scientist will develop robust, scalable processes for initial scale-up supporting animal studies and may spend up to 50% of their time hands-on in the laboratory supporting early route scouting and discovery scale-up toward CMC transition. The role authors technology-transfer documents and works with CROs and CDMOs to reproduce chemistry across sites. It supports RSM and DS manufacturing, scale-up for candidate selection, phase-appropriate process characterization, identification of critical quality attributes, and implementation of controls, including selection and justification of RSMs. The scientist helps ensure CRO and CMO systems and processes meet relevant regulatory standards and provide consistent DS quality, and prepares or reviews CMC sections of regulatory submissions. Travel may be up to 10%. The position is onsite in Brisbane, California.
Requirements
- PhD with 2–7 years of experience, or MS with 5 or more years of experience.
- Advanced degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, or a related scientific discipline.
- Strong working knowledge of synthetic organic chemistry and ability to apply it to route development and rapid synthetic triage.
- Experience analyzing experimental and analytical data.
- Ability 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 internal teams and external collaborators.
- Strong team orientation.
- Highly motivated, with interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Nice To Haves
- 2–5 years of relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
- Experience leveraging US and international CROs/CMOs to manufacture RSMs and DS to meet aggressive timelines.
- Experience with payload linker development for ADCs.
Responsibilities
- Own chemical development activities across the portfolio, including process development and manufacture of regulatory starting materials and support for drug substance production for clinical trial materials.
- Scout routes for preclinical and clinical candidates.
- Develop robust, scalable processes to support initial scale-up for animal studies.
- Work in the laboratory to support early route scouting and discovery scale-up efforts toward CMC transition, for up to 50% of the time.
- Author technology-transfer documents and work with CROs and CDMOs to reproduce chemistry at various sites.
- Support RSM and DS manufacturing activities at CRO/CDMO sites, including scale-up of candidate compounds for candidate selection during drug discovery.
- Support phase-appropriate process characterization, identify critical quality attributes, and implement controls, including selection and justification of RSMs.
- Help ensure CRO and CMO systems and processes comply with relevant regulatory standards and maintain consistency of DS quality.
- Prepare and/or review CMC sections of INDs, CTAs, NDAs, MAAs, and other regulatory submissions.
- Travel up to 10%.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
