Sr Scientist / Principal Scientist, Chemical Development

Initial Therapeutics, Inc.; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Sr Scientist/Principal Scientist in Chemical Development to lead the charge in developing novel immune modulators for cancer treatment. This role offers the opportunity to work in a dynamic environment where you'll oversee the manufacturing processes of regulatory starting materials and drug substances, ensuring compliance with stringent quality standards. You'll collaborate with cross-functional teams and represent the company before regulatory authorities, making a significant impact on the development of groundbreaking therapies. If you're passionate about advancing science and thrive in a fast-paced setting, this is the perfect opportunity for you.

Qualifications

• PhD or MS with extensive experience in Organic Chemistry or related fields.
• Experience in pharmaceutical CMC/cGMP environments preferred.

Responsibilities

• Develop scalable manufacturing processes for regulatory compliance.
• Support RSMs and DS manufacturing activities from preclinical to commercialization.

Skills

Organic Chemistry

Chemical Engineering

Pharmaceutical Chemistry

cGMP Manufacturing

Regulatory Filings

Analytical Data Analysis

Project Management

Communication Skills

Education

PhD in Organic Chemistry

MS in Pharmaceutical Science

Job description

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

• PhD with 5-7 years of experience or MS with 10+ years of experience; advanced degree in Organic Chemistry, Chemical Engineering, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
• 3-5 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
• Experienced with cGMP manufacturing and IND / IMPD and NDA / MAA filings; thorough knowledge of relevant FDA and EMEA regulations
• Strong working knowledge of synthetic organic chemistry and the ability to leverage it toward route development and rapid synthetic triage
• 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)