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Director, Manufacturing

1 month, 1 week ago
United States
Full-time
Lead
Operations Manager
Operations
Apply Now
Acadia Pharmaceuticals

Acadia Pharmaceuticals

Acadia Pharmaceuticals, with over 30 years of experience, pioneers essential therapies for Parkinson's disease psychosis and Rett syndrome, while focusing on addressing negative symptoms in various disorders.

Pharmaceuticals
251-1K
Founded 1993
$101M raised
View All Jobs 11

Description

  • Lead and coordinate commercial drug product manufacturing activities across a matrix team and external partners.
  • Manage all aspects of drug product manufacturing, including document authoring and revision, manufacturing oversight, deviations, investigations, and change actions.
  • Support product release and ensure finished product is delivered to the warehouse for distribution.
  • Lead the selection process for new commercial suppliers and alternative suppliers.
  • Develop and maintain manufacturing production timelines that are resource- and budget-loaded for near real-time tracking.
  • Coordinate periodic CMO manufacturing meetings, prepare minutes, and track action items to completion.
  • Maintain a consolidated manufacturing action log and drive completion of manufacturing-related actions on time.
  • Provide onsite process coverage as a person-in-plant as needed.
  • Collect and develop internal and external metrics to measure CMO and Acadia performance.
  • Communicate manufacturing and technology issues to production team members, TDO stakeholders, and project teams.
  • Supervise, train, and mentor personnel as needed.
  • Prepare Annual Product Reports with manufacturing CMOs.
  • Coordinate Steering Committee meetings with CMOs and Acadia participants.
  • Partner with Quality and Manufacturing SMEs to manage quality events and ensure timely resolution and closure.
  • Work with Quality Assurance to keep CMOs current and compliant with GMP requirements, guidelines, and procedures.

Requirements

  • BS, MS, or PhD in Engineering, Chemistry, or an equivalent combination of relevant education and applicable job experience.
  • Minimum of 12 years of progressively responsible experience in the pharmaceutical, biotechnology, or equivalent industry.
  • Experience with contract service providers.
  • Strong understanding of biopharmaceutical manufacturing, including regulatory filings and quality inspections and audits.
  • Strong business acumen.
  • Demonstrated experience preparing and reviewing annual product review or product quality review reports.
  • Extensive knowledge of current Good Manufacturing Practices (cGMPs).
  • Ability to operate effectively with a strong sense of urgency in a fast-paced environment.
  • Outstanding communication skills that are direct, clear, concise, and well organized.
  • Willingness and ability to travel domestically and internationally, with travel by car or airplane up to 30% of the time.
  • Experience in a hybrid work environment near Princeton, NJ or San Diego, CA is implied by the location preference.

Benefits

  • Competitive base salary of $174,100 to $217,600 USD.
  • Discretionary bonus eligibility.
  • Equity awards based on individual and organizational performance.
  • 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 of 1:1 up to 5%.
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in.
  • 15+ vacation days, 13–15 paid holidays, and office closure from December 24th to January 1st.
  • 10 days of paid sick time and paid parental leave.
  • Tuition assistance.

Interested in this position?

Apply directly on the company website

Apply Now

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