What are the responsibilities and job description for the Scientist I/Scientist II, Chemical Development position at Nurix Therapeutics?
Company
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.
Nurix Therapeutics (www.nurixtx.com) is a public biopharmaceutical company developing novel small molecule immune modulators for the treatment of cancer and autoimmune diseases. Based on the successful progress of our R&D platform, including expertise in medicinal chemistry, immune cell biology and in vivo pharmacology, Nurix is advancing multiple programs to the clinical stage. The company’s lead drugs are a novel protein degradation agent for blood borne tumors and a mechanistically novel oral, immunomodulatory agent for solid tumors.
The candidate will be responsible for chemical development-related 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, and establishment of associated control strategy for RSMs and DS to support CMC regulatory documents. The ideal candidate will be a highly motivated chemist with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Principal Duties and Responsibilities
- Development of robust, scalable, and cost-effective phase-appropriate manufacturing process that meet or exceed quality and regulatory requirements
- Work up to 50% of the time in the lab to support process route development and ongoing production campaigns
- Responsible for supporting RSMs and DS manufacturing related activities, including scale-up of compounds to support internal and external drug development
- Author tech transfer documents and work with CROs / CDMOs to effectively and efficiently reproduce chemistry at various sites
- 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, review, or edit technical reports, protocols, cGMP batch records, CMC regulatory submissions and Quality documents
- Collaborate with cross-functional teams, including analytical chemistry, formulation, quality and regulatory to support drug development programs
- Travel up to 25%
Skills and Background
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