Director, Drug Product Tech Ops

​Key Responsibilities:

• Leadership:Develop and execute strategic plans aligned with Axsome's goals for drug product development,manufacturing,supply,and global submissions.

• Technical Expertise:

  Provide in-depth knowledge of solid dosage unit processes,

  including direct blending,

  roller compaction,

  granulation,

  compression,

  and film coating.

• Operational Excellence:

  Oversee drug product manufacturing processes,

  collaborating with CMC development teams to ensure efficient,

  robust,

  and cost-effective commercial operations.

• Quality Assurance:

  Conduct thorough batch record reviews,

  ensuring accuracy and completeness for timely release of commercial batches.

  Review and provide expert input on investigations related to manufacturing deviations,

  OOS results,

  and other quality incidents.

• Cross-Functional Collaboration:

  Work seamlessly with CMC,

  Regulatory Affairs,

  Quality Assurance,

  and Supply Chain teams to drive alignment and ensure successful product development and commercial launch.

• Process Improvement:

  Implement best practices,

  process improvements,

  and advanced manufacturing technologies to enhance productivity,

  quality,

  and cost-effectiveness.

• Validation & Verification:

  Lead the design and execution of process validation activities,

  including protocol development and report writing.

  Establish and maintain a robust in-process control strategy and continuous process verification program.

• Data-Driven Approach:

  Employ statistical process control techniques and data analysis to drive process improvements and ensure consistent product quality.

• Regulatory Support:

  Provide technical expertise and authoring/reviewing support for module 3 sections of regulatory submissions related to drug product development and manufacturing.

• Vendor Management:

  Manage relationships with CMOs,

  ensuring seamless and robust drug product manufacturing that adheres to established global quality and compliance standards.

• Quality Oversight:

  Collaborate with the QA team to provide on-site PIP oversight and CMO audit support,

  as necessary.