Associate Director of Technical Operations
2 days ago
Axsome Therapeutics, Inc. is a biopharmaceutical company dedicated to developing and delivering innovative therapies for the management of central nervous system (CNS) disorders. Our team is a dynamic group of professionals committed to addressing unmet needs for patients with CNS disorders. Our company is based in New York City.
About This RoleAxsome Therapeutics is seeking an Associate Director/Director of Drug Product Technical Operations who will play a crucial role in the effective management of contract manufacturing organizations (CMOs) and external manufacturing partners, technology transfer, process validation, and ongoing process verification for commercial products. This role will involve key cross-functional interactions with the CMC, supply chain, clinical operations, regulatory, quality, and management teams.
Key Responsibilities- 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.
- 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, and Thursday.
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Associate Director of Technical Operations
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New York, New York, United States Axsome Therapeutics, Inc. Full timeAbout Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company dedicated to developing and delivering innovative therapies for the management of central nervous system (CNS) disorders. Our team is a dynamic group of professionals committed to addressing unmet needs for patients with CNS disorders. We are based in New York City.About...
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