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 an Associate Director/Director, Drug Product Technical Operations. This position will be crucial to the effective management of contract manufacturing organizations (CMOs) and external manufacturing partners, technology transfer, process validation, and ongoing process verification for the commercial products. The position reports to the Senior Director, CMC Drug Product Commercial Manufacturing and will manage essential duties and responsibilities independently. Key interactions will be with the CMC, supply chain, clinical operations, regulatory, quality and management teams.
This role is based at Axsome’s HQ in New York City.
Job Responsibilities and Duties include, but are not limited to, the following:
- Develop and implement strategic plans, objectives, and initiatives to support the Axsome’s drug product development, commercial manufacturing, supply, and global submission goals
- Oversee drug product manufacturing processes, including collaboration with CMC development (formulation, process development, scale-up, and technology transfer), to ensure efficient and robust commercial manufacturing operations
- Provide technical expertise on various solid dosage unit processes including direct blending, roller compaction, high shear and low shear granulation, compression, and film coating
- Conduct thorough reviews of batch records to ensure accuracy and completeness ensuring timely release of commercial batches
- Review and provide expert input on investigations related to manufacturing deviations, out-of- specification (OOS) results, and other quality-related incidents
- Collaborate with cross-functional teams, including within CMC, Regulatory Affairs, Quality Assurance (QA), and Supply Chain, to drive alignment and ensure successful product development and commercial product launch
- Implement best practices, process improvements, and advanced manufacturing technologies to enhance productivity, quality, and cost-effectiveness
- Participate in design and execution of process validation activities for drug product manufacturing, including protocol development and process validation report writing
- Establish and maintained a robust in-process control strategy and continued process verification (CPV) program to ensure proactive control and monitoring of commercial product manufacturing
- Implement statistical process control techniques and data analysis to drive process improvements and ensure consistent product quality
- Provide technical expertise and support for regulatory submissions, including authoring and review of module 3 sections, related to drug product development and manufacturing
- Manage relationships with contract manufacturing organizations (CMOs) to ensure seamless and robust drug product manufacturing and adherence to established global quality and compliance standards
- Collaborate with QA team to provide on-site person-in-plant (PIP) oversight and CMO audit support, as needed
Requirements / Qualifications
- Bachelor’s, Master’s or Ph.D. degree (advanced degree a plus) in pharmaceutical sciences, chemical engineering, or a relevant scientific/engineering discipline required
- A minimum of 8-10 years of experience in commercial drug product manufacturing
- Solid knowledge and understanding of CMC and process development required
- Strong experience in external vendor management and working with contract manufacturing organizations (CMOs)
- Proficiency in utilizing statistical software tools such as JMP and Minitab
- Excellent communication skills, with the ability to effectively collaborate with cross-functional teams, external partners, and regulatory agencies
- Requires exceptional organizational skills with the ability to multi-task and prioritize workload based upon changing priorities
- Willingness to travel periodically as needed
- Ability to work on site Monday, Tuesday & Thursday
Experience and Knowledge
- Solid knowledge of pharmaceutical dosage forms, scale-up, technology transfer, and manufacturing including validation and commercialization
- In depth knowledge of FDA regulatory requirements related to commercial drug product manufacturing and process validation, ICH guidelines and requirements of NDA and IND’s
- Extensive experience in commercial drug product manufacturing, process validation including hands on experience with CPV, statistical analysis, and process capability assessment
- Strong analytical and problem-solving skills, with the ability to apply statistical methods to process optimization and control and draw meaningful conclusions
- Proven experience in managing relationships with external CMOs, ensuring quality and compliance, while driving performance
- Additional skills/qualifications for the role, including any that are preferred but not required
Salary & Benefits
The anticipated salary range for this role is $150,000–$180,000. 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 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.
