Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City.
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
- BS degree in a scientific discipline strongly preferred
- 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 - $93,000. 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.