New · posted Nov 11
Axsome Therapeutics · Pharmaceuticals
Specialist, Quality Control
- New York, NY
- Hybrid
- Full-time
- Associate & Specialist
The role
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.
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
What you need
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
Pay
$75,000 – $85,000 a year
Employer providedSalary & 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.
Where you'll work
New York, NYHybridOpen in Maps (opens in a new tab)
More jobs in New York, NYEqual opportunity, accessibility and legal noticesAxsome Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in New York23 roles publishing pay
Associate & Specialist roles in the US90 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $75,000 | — | $85,000 |
| New York (middle half) | $62,500 | $66,000 | $78,500 |
| All US (middle half) | $64,000 | $73,500 | $88,250 |
This role: Axsome Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 265 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Axsome's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods8
- Documentation and SOPs5
- Data and digital systems4
- GMP and compliance3
- Collaboration and leadership2
- Investigations and CAPA1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in pharmaceuticals, led by the four this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug productsNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
Company hiring pulse
Axsome on Regulatory Jobs
- 7
- Open roles
- 7
- Distinct roles
- 1
- Locations
By discipline
- Clinical5 71%
- Quality2 29%
By level
- Manager3 43%
- Associate & Specialist2 29%
- Director1 14%
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Specialist, Quality Control at Axsome
Open until filled. $75K–$85K a year, employer provided.