Director Manufacturing
Posted on 3/22/2024
Acadia Pharmaceuticals Inc.

501-1,000 employees

Develops therapies for central nervous system disorders.
Company Overview
Acadia Pharmaceuticals Inc. stands out as a leader in the healthcare industry with over 25 years of experience, particularly noted for developing the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. The company's culture is characterized by a dedicated team of "care-ageous warriors" who are committed to improving the lives of patients and their families. Acadia's competitive edge lies in its robust late-stage development efforts focused on dementia-related psychosis, negative symptoms of schizophrenia, and Rett syndrome, as well as early-stage clinical research exploring novel approaches to pain management, cognition, and neuropsychiatric symptoms in central nervous system disorders.
Biotechnology

Company Stage

N/A

Total Funding

$813.4M

Founded

1993

Headquarters

San Diego, California

Growth & Insights
Headcount

6 month growth

6%

1 year growth

19%

2 year growth

20%
Locations
Princeton, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Mechanical Engineering
Manufacturing Engineering
Robotics and Automation Engineering
Requirements
  • Bachelor's degree in Engineering, Chemistry or related field. MBA preferred.
  • 12 years of progressively responsible experience within the pharmaceutical, biotech, or equivalent industry.
  • Contract service provider experience.
  • Strong understanding of biopharmaceutical manufacturing including regulatory filings and quality inspections and audits.
  • Strong business acumen.
  • 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.
Responsibilities
  • Leads manufacturing activities and coordinating activities across a matrix team.
  • 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.