CMC Analytical Contractor

Summary

Join Syndax Pharmaceuticals as a Contractor, CMC Analytical and contribute to the development of innovative cancer therapies. You will be responsible for analytical development activities for a preclinical pipeline program, collaborating with external and internal teams. Key responsibilities include defining analytical strategies, managing vendor activities, and ensuring compliance with regulatory standards. The ideal candidate possesses a degree in a relevant science field, extensive experience in analytical science within pharma/biotech, and expertise in various analytical technologies. This role requires strong communication and problem-solving skills, and involves domestic and international travel. Syndax offers a dynamic work environment focused on reimagining cancer care.

Requirements

• Degree in chemistry, biochemistry, pharmacy, analytical sciences or related sciences is required
• At least 10 years of focused experience in analytical science within pharma/biotech organizations
• Small molecule drug substance and drug product analytical experience
• 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

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
• 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

Preferred Qualifications

• Advanced degree is preferred
• 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
• Business travel, domestic and international, to company office and CMOs as required