What are the responsibilities and job description for the Scientist I/Scientist II, Chemical Development position at Initial Therapeutics, Inc.?
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.
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 compliance with all relevant regulatory standards and 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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