Director, Manufacturing

Acadia Pharmaceuticals Inc.•San Diego, CA

4h•Hybrid

About The Position

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. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. Seeking talent near: Princeton, NJ ; San Diego, CA Position Summary: Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMO’s), 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.

Requirements

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.
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.

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.

Benefits

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