Manager/Senior Manager, Regulatory CMC

Axsome Therapeutics is seeking a Manager/Senior Manager, Regulatory CMC to provide regulatory Chemistry Manufacturing Controls (CMC) support for assigned corporate development and commercial programs. The role will assist the Regulatory CMC Team and CMC Team with various tasks, including drafting documents, acquiring supportive documentation, and entering data into draft documents. The role will also participate in CMC and CDMO meetings, monitor changes to APIs, excipients, and test methods, and interact with CMC vendors.

Requirements

• Master's or Ph.D. degree in chemistry or associated science preferred with 1– 3 years of relevant Regulatory CMC experience in the Biotechnology or Pharmaceutical industry
• Bachelor's degree in a life science with at least 5 years of Regulatory CMC experience may be considered
• Experience with solid oral dosage forms
• Understanding of eCTD requirements, FDA electronic gateway submissions, CDER guidance's, CDER MAPPS, ICH guidelines, USP, and EP

Benefits

• Annual bonus
• Significant equity
• Generous benefits package