Director, Manufacturing

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 Acadia’s 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 Acadia’s 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:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range$173,000—$216,200 USD

What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages
• Medical, dental, and vision insurance
• Employer-paid life, disability, business travel and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 5%
• Employee Stock Purchase Plan with a 2-year purchase price lock-in
• 15+ vacation days
• 13 -15 paid holidays, including office closure between December 24th and January 1st
• 10 days of paid sick time
• Paid parental leave benefit
• Tuition assistance