Associate Manager, Technical Operations

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role 

Axsome Therapeutics is seeking a results-driven Associate Manager, Technical Operations with experience in pharmaceutical manufacturing and process validation that is adept in applying advanced statistical methods (ANOVA, MANOVA, process capability) to evaluate process consistency and improve quality outcomes.  

This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.  

Job Responsibilities and Duties include, but are not limited to, the following: 

• Prepare and review technical transfer documents, validation protocols and reports 

• Prepare and review Continued Process Verification (CPV) documents including statistical trending, control charting and process capability analysis and play a significant role in continuous improvement efforts 

• Provide on-site support and technical leadership for tech transfer and scale up activities and of process performance qualification (PPQ) for new and existent products 

• Lead and support day-to-day technical operations for commercial drug product manufacturing, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines 

• Provide technical expertise for investigations of OOS/OOT, deviations, identifying root causes and implementing CAPAs