Drug Product Contractor

Summary

Join Syndax Pharmaceuticals as a Contractor, Drug Product and contribute to the development of innovative cancer therapies. This role focuses on formulation and process development for preclinical pipeline programs. You will collaborate with external CDMOs and internal teams, managing activities, timelines, and budgets. Responsibilities include leading drug product development, managing vendors, monitoring CDMO work, troubleshooting issues, and preparing regulatory filings. The ideal candidate possesses a relevant scientific degree and extensive experience in small molecule drug product development. Location is flexible, with a preference for East Coast locations.

Requirements

• Degree in a relevant scientific discipline; Ph.D. (preferred) in relevant discipline and 8+ years relevant work experience or B.S./M.S. in relevant discipline and 12+ years relevant work experience
• Small molecule drug product experience required
• Experience in designing and developing solid and liquid oral formulations (such as IR, MR, ODTs) and associated processes for small molecules in support of clinical and preclinical studies
• Understanding of cGMPs and regulatory guidance

Responsibilities

• Lead drug product development activities and define phase-appropriate strategies for small molecule drug product development and manufacture
• Participate in developing work scope plans and identifying and selecting drug product formulation development and manufacturing vendors with required capabilities
• Manage activities, timelines, and budgets at CDMO/CROs conducting manufacturing, testing, and packaging activities to meet overall project timelines
• Monitor work performed by drug product CDMOs, including reviews of protocols, reports, raw data, master and executed production records to ensure consistency with project and regulatory requirements and scientific integrity
• Work in a fast-paced environment to meet project goals and timelines
• Troubleshoot formulation and manufacturing issues as needed
• Participate in and collaborate with cross-functional teams to align with their timelines and advance programs
• Document development activities reports and identify issues to address with the cross-functional team
• Author, review and approve GMP documents for clinical supply manufacturing
• Support any quality investigations or events and resolve them in a timely manner
• Prepare drug product sections of regulatory filings, ensuring accuracy and consistency with regulatory guidance documents

Preferred Qualifications

• Experience with formulation of poorly soluble APIs and bioavailability enhancement techniques is a plus
• Experience in designing and optimizing manufacturing processes for oral drug products
• Able to manage multiple internal and external activities to meet timelines
• Prior experience managing outsourced development and manufacturing
• 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