Director, Manufacturing

Seeking talent near: Princeton NJ ; San Diego CA

Position Summary:

Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMOs) and other third-party suppliers for products as identified. Responsible for tracking of ongoing manufacturing schedules to ensure commercial supply levels are maintained and inventory targets are met. Responsible for technical and business evaluation of manufacturing network.

Primary Responsibilities:

• Team and Project Leadership capable of leading manufacturing activities and coordinating activities across a matrix team. A SME in DP manufacturing knowledgeable in development quality and regulatory requirements for manufacturing.
• Manage all aspects of DP Manufacturing from authoring and revision of manufacturing documents (MBRs Protocols QRAs etc) oversight of manufacturing operation managing deviations investigations and relevant change actions supporting product release and ensuring the finished product arrives in warehouse for distribution.
• Responsible for DP vendor selection process for new commercial suppliers or for alternative suppliers.
• Develops and maintains good working relationships with contract manufacturers.
• Develop and maintain Drug Product manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource.
• Coordinate periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items.
• Maintains and follow through a consolidated Acadia Manufacturing action log to ensure all manufacturing related actions are completed on time.
• Provide onsite process coverage as person-in-plant as needed
• Develops collects appropriate internal and external metrics to measure CMO and Acadias performance.
• Communicates manufacturing or technology related issues and information to Manufacturing production team members TDO stakeholders and other members of the project team.
• Supervise train and mentor personnel as needed.
• Prepare Annual Product Reports with Manufacturing CMOs according to Acadias needs.
• Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings.
• Works with Quality Group and Acadia Manufacturing SMEs to ensure Quality Events are managed and communicated appropriately to ensure timely resolution and closure.
• With Quality Assurance ensures CMOs remain current and compliant with all GMP related requirements guidelines and procedures.

Education/Experience/Skills:

BS MS or PhD in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. A minimum of 12 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.

Must possess:

• Contract service provider experience.
• Strong understanding is required of biopharmaceutical manufacturing including regulatory filings and quality inspections and audits.
• Strong business acumen.
• Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
• Extensive knowledge of current Good Manufacturing Practices (cGMPs)
• Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
• Outstanding communicator: direct effective clear concise well organized and appropriate.
• Domestic and International travel is required for this role.

Physical Requirements:

While performing the duties of this job the employee is regularly required to stand; walk; sit; use hands to finger handle or feel; reach with hands and arms; climb or balance; stoop kneel crouch see talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel by car or airplane independently up to 30% of the time and work after hours if required by travel schedule or business issues.

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