Contractor, CMC Analytical
Syndax Pharmaceuticals is looking for a Contractor, CMC Analytical
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, CMC Analytical will be responsible for analytical 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 drug substance and drug product 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:
- Define analytical development and control strategies suitable for early clinical development.
- Identify and assess capabilities of vendors to conduct analytical testing in support of development.
- Manage activities, timelines, and budgets for analytical activities at vendors.
- Provide strategic and technical leadership for the phase-appropriate analytical method development, optimization, qualification and validation of drug substance and drug product at vendors. As required, design analytical studies to be performed by selected outsourced vendors.
- Partner with process chemists and formulation scientists to develop and assess testing strategies and plans in support of drug substance and drug product development.
- Design and manage drug substance and drug product stability study programs at vendors.
- Review analytical work performed by vendors, including reviews of protocols, reports, methods, in-process, intermediate, and finished product release and stability testing to ensure accuracy and consistency with project and regulatory requirements.
- Ensure analytical practices are in conformance with current global regulatory and compliance standards and Syndax standards.
- Prepare reports for management and identify issues to address with the cross-functional team.
- Prepare analytical sections of regulatory filings, ensuring accuracy and consistency with regulatory guidance.
Desired Experience/Education and Personal Attributes:
- Degree in chemistry, biochemistry, pharmacy, analytical sciences or related sciences is required, and advanced degree is preferred. At least 10 years of focused experience in analytical science within pharma/biotech organizations; small molecule drug substance and drug product analytical experience required.
- Prior experience in managing analytical aspects of outsourced development and manufacturing.
- Technical expertise in various analytical technologies including chromatography (LC, GC), mass spectrometry (LC-MS, GC-MS), solid state characterization (XRPD, DSC, PSD, TGA), wet chemistry, dissolution testing, various spectroscopic and compendial techniques.
- Understanding of cGMPs and regulatory guidance. Previous experience in authorship of analytical sections of regulatory documents is highly preferred.
- Must be able to effectively manage multiple concurrent activities and problem solve to achieve business needs.
- Strong communication skills, able to work independently and collaborate 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.
#LI-Remote
Apply for this job
*
indicates a required field