Specialist, Quality Control

Axsome Therapeutics•New York, NY

2h•$75,000 - $85,000•Hybrid

About The Position

Axsome Therapeutics is seeking a Specialist, Quality Control to support management of analytical data and stability studies for its commercial drug portfolio. The role contributes to Quality Control activities, ensuring compliance with GMP principles and collaborating with cross-functional groups. It reports to the Senior Director, QC. The position is based at Axsome’s headquarters in New York City and requires onsite work at least three days per week, specifically Monday, Tuesday, and Thursday. Fully remote candidates will not be considered.

Requirements

BS/BA in life science or a related field.
At least 2 years of QC/QA experience in the pharmaceutical or biotechnology industry.
Ability to work onsite Monday, Tuesday, and Thursday; fully remote candidates will not be considered.
Strong understanding of data integrity in a GMP environment.
Understanding of pharmaceutical stability study design and ICH Q1.
Ability to assess, comprehend, and analyze analytical raw data and results.
Experience with Veeva LIMS and Vault or equivalent.

Responsibilities

Compile and enter analytical release and stability data into LIMS for CoA and stability report generation.
Provide feedback on the design and workflow of the stability module in LIMS.
Track stability pulls, testing timelines, and reporting deadlines at CMO/CROs.
Assist with trending release and stability data.
Assist in preparing internal metrics presentations.
Support documentation and investigation of OOS/OOT results and laboratory investigations.
Contribute to authoring and reviewing 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.