Specialist, Quality Control

The role

This person will support the management of analytical data and stability studies for a commercial drug portfolio. They will perform Quality Control activities ensuring compliance and applying GMP principles.

What you will do

• Compile and enter analytical release and stability data into LIMS
• 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 QA, analytical development, and other functional groups
• Ensure compliance with applicable GMP regulations, ICH guidelines, and SOPs

Required qualifications

• BS/BA in life science or related field
• 2+ years' experience in QC/QA within the pharmaceutical or biotechnology industry
• Ability to work on site Monday, Tuesday & Thursday
• 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

Benefits

• Annual bonus
• Significant equity
• Generous benefits package

About the company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. Their 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.