Please note that this position is based in Princeton, NJ. Acadia’s hybrid model requires this role to work in our office three days per week on average.

The Director of Manufacturing is the Business lead, Technical Lead and primary contact responsible for managing Acadia’s commercial Drug Product (DP) Contract Manufacturing Organizations (CMO’s), and other third-party suppliers. This position will also oversee the tracking of ongoing manufacturing, implementing process improvements, completion of quality investigations, and ensure commercial supply levels are maintained. The position will be responsible ongoing technical and business evaluation of the global manufacturing network.

Primary Responsibilities

• Leads manufacturing activities and coordinating activities across a matrix team. A subject matter expert (SME) in DP manufacturing with extensive knowledgeable in development, quality, and regulatory requirements for manufacturing.
• Manages all aspects of DP Manufacturing from authoring and revision of manufacturing documents (MBRs, Protocols, QRAs, etc.), including 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 alternative suppliers.
• Develops and maintains good working relationships with contract manufacturers.
• Develops and maintains DP manufacturing production timeline that is resource and budget loaded to ensure near real time tracking of production and resource.
• Coordinates 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.
• Provides onsite process coverage as person-in-plant as needed.
• Develops, collects appropriate internal and external metrics to measure CMO and Acadia performance.
• Communicates manufacturing or technology related issues and information to Manufacturing production team members, department stakeholders, and other members of the project team.
• Supervise, train and mentor personnel as needed.
• Prepare Annual Product Reports with Manufacturing CMOs according to Acadia’s needs.
• Work with CMOs and Acadia colleagues to schedule and coordinate Steering Committee Meetings.
• Works with Quality and 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.
• Other duties as assigned.

Education and Experience

• Bachelor’s degree in Engineering, Chemistry or related field. MBA preferred.
• Targeting 12 years of progressively responsible experience within the pharmaceutical, biotech, or equivalent industry.
• An equivalent combination of relevant education and experience may be considered.
• 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).
• Ability to support multiple projects while being well-organized and able to meet timelines/deliverables.
• Strong attention to detail and problem-solving skills.
• Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines.
• 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.
• Able to make sound decisions and prioritize process and resource decisions based on overall team needs.
• Domestic and International travel, up to 50%, 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 independently overnight up to 50% of the time and work after hours if required by travel schedule or business issues.

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