Quality Control Specialist

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

• Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles

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

Salary & Benefits

The anticipated salary range for this role is $75,000 - $85,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.