Drug Substance Contractor

Summary

Join Syndax Pharmaceuticals as a Contractor, Drug Substance and contribute to the development of innovative cancer therapies. This role involves leading API development, collaborating with CDMOs, troubleshooting manufacturing issues, and overseeing solid form studies. You will work closely with cross-functional teams, manage multiple projects, and contribute to regulatory filings. The ideal candidate possesses a PhD in synthetic organic chemistry with extensive experience in CMC within pharma/biotech. This position offers the flexibility of remote work with a preference for East Coast locations.

Requirements

• PhD degree in synthetic organic chemistry with at least 10 years of small molecule experience in CMC function in pharma/biotech organizations
• Deep mechanistic understanding of classical and modern synthetic reactions to troubleshoot issues during development
• Understanding of cGMPs and regulatory guidance
• Able to manage multiple concurrent internal and external activities to meet timelines
• Strong attention to details and problem-solving skills, as well as the ability to work in a cross-functional team environment
• Excellent communication skills, able to work independently and collaboratively with key internal and external stakeholders
• Must be flexible in adapting to a changing work environment and offer solutions to program challenges

Responsibilities

• Lead API development activities and define phase-appropriate strategies for small molecule drug substance development and manufacture
• Provide guidance to CDMOs on route scouting and route optimization, define GMP starting points as appropriate for the phase of the program
• Troubleshoot development and manufacturing issues as needed
• Oversee solid form studies such as salt and crystal form selections
• Ability to identify impurity structures based on chemistry and analytical techniques (LC-MS, MS/MS, 2D-NMR etc.)
• Perform process safety and scalability assessments of selected routes in collaboration with CDMOs
• Take bottom-up approach to select safer reagents and solvents for smoother transition to later phases
• Contribute to intellectual property/patent related activities
• Work in a fast-paced environment to meet project goals and timelines
• Monitor work performed by CDMOs, including review of protocols, reports, raw data, methods and master/executed batch records
• Collaborate with cross-functional teams to align with their timelines and advance programs
• Document developmental activities by providing memos and reports as appropriate
• Prepare drug substance sections of regulatory filings, ensuring accuracy and consistency with regulatory guidance

Preferred Qualifications

Business travel, domestic and international, to company office and CMOs as required

Benefits

#LI-Remote