Specialist, Quality Control
Required skills
- analytical data
- stability studies
- CoA
- stability report
- LIMS
- CMO/CRO
- trending
- metrics
- OOS/OOT
- lab investigations
Nice to have
- data integrity
- pharmaceutical stability study design
- ICH Q1
Role summary
Axsome Therapeutics, a biopharmaceutical company focused on CNS conditions, seeks a Specialist, Quality Control to manage analytical data and stability studies for its commercial drug portfolio. This role ensures compliance with GMP principles, collaborates with cross-functional teams, and contributes to quality control activities. Responsibilities include data compilation in LIMS, tracking stability studies, data trending, assisting with investigations, and authoring/reviewing QC documents. The position requires a BS/BA in a life science field, 2+ years of QC/QA experience in pharma/biotech, and strong understanding of data integrity and stability study design. The role is based in New York City with a hybrid on-site requirement.
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:
Requirements / Qualifications
Experience, Knowledge and Skills
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.
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