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 of Drug Product Technical Operations who 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; including key cross functional interactions with the CMC, supply chain, clinical operations, regulatory, quality and management teams. The position reports to the Sr. Director of Tech Ops for Drug Product Commercial Manufacturing and will manage essential duties and responsibilities as independently as possible.
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:
- Develop and implement strategic plans, objectives, and initiatives to support Axsome's drug product development, commercial manufacturing, supply, and global submission goals.
- Oversee drug product manufacturing processes, including formulation, process development, scale-up, and technology transfer, to ensure efficient and robust commercial manufacturing operations.
- Author process validation protocols, coordinate the execution and prepare detailed validation reports for commercial products.
- Facilitate the technology transfer of new processes and products from R&D to manufacturing ensuring seamless integration and scale up; manage the transfer of established manufacturing processes between different production sites both domestically and internationally.
- Review commercial batch records, investigations related to manufacturing deviations, out-of-specification (OOS) results, and other quality-related incidents.
- Collaborate with cross-functional teams, including CMC, Regulatory Affairs, Quality Assurance (QA), and Supply Chain, to drive alignment and ensure successful product development and commercial product launch.
- Establish and maintain a robust in-process control strategy and continued process verification (CPV) program to ensure proactive control and monitoring of commercial product manufacturing.
- Author comprehensive continued process verification (CPV) protocols that outline the methodologies, procedures, and parameters for ongoing monitoring. Analyze data to identify trends, variances, and potential areas for improvement, and prepare detailed CPV reports that summarize findings, including statistical analysis, charts, and graphs to present data clearly.
- 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.
- 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
- Advanced degree (Ph.D., M.Sc., or equivalent) in pharmaceutical sciences, chemical engineering, or a relevant scientific/engineering discipline.
- A minimum of 10 years of experience in commercial drug product manufacturing.
- Strong experience in external vendor management and working with contract manufacturing organizations (CMOs).
- Proficiency in utilizing statistical software tools such as JMP and Minitab.
- Ability to work on site Monday, Tuesday & Thursday.
Experience, Knowledge and Skills
- 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 INDs.
- Solid knowledge and understanding of CMC and process development required.
- 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.
- 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.
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 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.
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