Specialist, Quality Control
Axsome Therapeutics
Summary
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.
Job description
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.
Job Responsibilities and Duties
- 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
- Ability to work on site Monday, Tuesday & Thursday
Experience, Knowledge and Skills
- 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
Requirements
- 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
- Equity
- Benefits Package
Company overview
Axsome Therapeutics is a biopharmaceutical company focused on developing and commercializing novel therapies for central nervous system (CNS) disorders. The company has built a robust pipeline targeting major depressive disorder, migraine, Alzheimer's disease agitation, and other neurological conditions. Axsome's lead product, Auvelity (dextromethorphan-bupropion), received FDA approval for the treatment of major depressive disorder in adults, representing a significant advancement in depression treatment with a novel mechanism of action. The company's development strategy focuses on leveraging known active pharmaceutical ingredients in novel combinations or formulations to create differentiated therapies with improved efficacy and safety profiles. Axsome employs a targeted approach to CNS disorders where significant unmet medical needs exist, combining scientific innovation with strategic clinical development to bring meaningful treatments to patients suffering from debilitating neurological conditions.