What are the responsibilities and job description for the Sr Scientist/Principal Scientist, Chemical Development position at Initial Therapeutics, Inc.?
JOB DESCRIPTION : Sr Scientist / Principal Scientist, Chemical Development – Nurix Therapeutics
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 support production of Drug Substance (DS) for clinical trial materials, and establishment of associated Control Strategy for RSMs and DS to support IND / NDA filing and commercial manufacturing. 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 processes 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.
- Author technical reports to support regulatory filings
- Responsible for supporting RSMs and DS manufacturing related activities, including scale-up of candidate compounds to support candidate selection during drug discovery, from preclinical development through commercialization
- 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
- Support the characterization of late phase programs according to the principles of QbD (mapping studies, DOEs) to identify critical quality attributes and critical process parameters (including edge of failure and proven acceptable ranges) and implement DS Control Strategy to support NDAs / MAAs
- Support management of RSMs and DS supply chain and logistics in support of demand for clinical studies and commercial products
- Support process validation programs to support commercialization
- Prepare and / or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; represent the company as the DS expert before U.S. and European regulatory authorities
- Prepare, review, or edit cGMP batch records, CMC regulatory and Quality documents
- Travel up to 25%
Skills and Background
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