Associate Director, Manufacturing (Drug Substance)

About the role

The Associate Director of Manufacturing is responsible for the oversight of commercial Contract Manufacturing Organizations and third-party suppliers. This role manages the transfer of processes from R&D to commercial suppliers and ensures that manufacturing schedules, quality standards, and inventory targets are met. The position requires strategic collaboration with internal teams to optimize manufacturing processes and ensure compliance with regulatory requirements.

Responsibilities

• Develops and maintains good working relationships with contract manufacturers.
• Negotiate and manage CMO contracts
• Develops SOP’s and work processes needed for Commercial Manufacturing
• Works with CMOs to diagnose and correct process issues.
• Identifies, evaluates and selects CMOs for the manufacture of Commercial products
• Develops, collects appropriate metrics to measure CMO performance; leads CMO partnership teams.
• Works with Quality Group to determine the impact of process deviations and works towards resolutions
• Develops timelines, goals, and deliverables for API and related manufacturing processes.
• Optimizes the manufacturing process to maintain high product quality, improve process portability, increase process robustness, improve process efficiency, and reduce manufacturing costs.
• Assists in developing drug substance sourcing strategies.
• With Quality Assurance, ensures CMOs remain current and compliant with all GMP related requirements, guidelines and procedures.
• Tracks deviations and processes changes for the different suppliers and collaborate with Regulatory Affairs and Quality Assurance in assessing their impact on regulatory filings.
• Initiates and coordinates the preparation of CMC documentation as required
• Collaborates with Regulatory Affairs and other groups to support product filings.
• Assists in contract site preparation activities for regulatory inspections.
• Supports interdisciplinary working teams with recommendations, advice and action plans for manufacturing related issues.
• Provide onsite process coverage as person-in-plant as needed
• Communicates manufacturing or technology related issues and information to committees, teams and interested groups within the company.
• Supervise, train and mentor personnel as needed.

Required skills

• Manufacturing
• Contract Manufacturing
• GMP
• CMC documentation
• Regulatory filings
• Quality inspections

Qualifications

• BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience
• Master's degree
• Ph.D.

About the Company

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.