Specialist, Quality Control

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, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates 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 Specialist, Quality Control to support the management of analytical data and stability studies for our commercial drug portfolio. This role will contribute to a range of Quality Control activities ensuring compliance, applying GMP principles, and collaborating with cross-functional groups. This role reports into the Senior Director, QC.      

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: 

• Compile and enter analytical release and stability data into LIMS for CoA and stability report generation 

• Provide feedback on design and workflow of stability module in LIMS 

• Track stability pulls, testing timelines, and reporting deadlines at CMO/CROs 

• Assist with trending of release and stability data 

• Assist in the preparation of internal metrics presentations 

• Support in the documentation and investigation of OOS/OOT results and lab investigations 

• Contribute to the authoring and review of QC SOPs, specifications, and technical reports 

• Collaborate with, and support, QA, analytical development, and other functional groups to ensure timely product release 

• Ensure compliance with applicable GMP regulations, ICH guidelines, and SOPs 

Requirements / Qualifications 

• BS/BA in life science or related field 

• 2+ years' experience in QC/QA within the pharmaceutical or biotechnology industry