Syndax Pharmaceuticals is looking for a Contractor, Drug Substance
At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.
The Role:
The Contractor, Drug Substance position will be responsible for process development activities for one of our preclinical pipeline programs. The suitable candidate will collaborate closely with external contract development and manufacturing organizations (CDMOs) as well as internal groups including analytical and formulation development, quality assurance, regulatory, and supply chain. They will be a core member of the program CMC development team and communicate progress within and outside of the function.
Key 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.
Desired Experience/Education and Personal Attributes:
- 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.
- Business travel, domestic and international, to company office and CMOs as required.
Location: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.
About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn.
Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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