Specialist/Senior Specialist, Quality Assurance

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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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 Quality Assurance Specialist/Senior Specialist to focus on ensuring compliance with Good Manufacturing Practices (GMP) with all work performed. The QA Specialist/Senior Specialist will provide the Quality Assurance team oversight of external manufacturing activities to ensure consistent compliance with company procedures, regulations, and industry expectations.

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:

• Review executed batch production records for completeness, GDP and ALCOA requirements

• Communicate and resolve discrepancies with third-party CMOs

• Perform release of all manufactured, packaged and tested materials (including but not limited to raw materials, intermediates and drug products)

• Ensure timely escalation to management of all applicable incidents

• Review test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards

• Initiate and track quality events (deviations, change controls, CAPAs) in Axsome’s eQMS through closure

• Work collaboratively with internal departments to respond to and resolve deviations and OOSs

• Provide support in the review and approval of cGMP-controlled documents such as master batch records, test methods, and specifications

• Provide support in the review of change controls related to manufacturing, analytical test methods, and specifications to meet cGMP and internal standards

• Support the annual product review process

• Provide QA support for process validations including reviewing protocols and reports

• Contribute to the refinement and ongoing improvement of manufacturing processes and documentation at various CMO locations

• Write and review Standard Operating Procedures, as needed

• Support the development, implementation, and improvement of corporate quality management systems that support late phase clinical and commercial programs.

• Support regulatory agency inspections as needed

• Support the development and reporting of site Quality Metrics

Requirements / Qualifications

• Bachelor’s degree required with a preference within a scientific discipline

• 2-5 years of relevant Quality Control or Quality Assurance experience in a GMP- regulated commercial environment

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

Experience and Knowledge

• Proficient knowledge of GMP regulations and guidance documents

• At least 1 year experience reviewing manufacturing batch records is preferred

• Experience working in Quality Assurance Operations with a strong focus on Batch Record Review and Shop Floor support

• Experience supporting clinical manufacturing operations is a plus

• Strong attention to detail

• Excellent interpersonal and communication skills (both written and verbal)

• Proven ability to multitask projects of varying complexity

Salary & Benefits

The anticipated salary range for this role is $85,000 - $95,000. 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.