Director, Manufacturing
Acadia Pharmaceuticals
1 month ago
Remote friendly (Princeton, NJ)
United States
Operations
Position Summary:
- Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMOs) and other third-party suppliers for identified products.
- Track ongoing manufacturing schedules to maintain commercial supply levels and meet inventory targets.
- Responsible for technical and business evaluation of the manufacturing network.
Primary Responsibilities:
- Lead and coordinate manufacturing activities across a matrix team; subject-matter expert in DP manufacturing, knowledgeable in development, quality, and regulatory requirements.
- Manage DP manufacturing: author/revise manufacturing documents (MBRs, Protocols, QRAs, etc.), oversee manufacturing operations, manage deviations and investigations, execute change actions, support product release, and ensure finished product arrives in warehouse for distribution.
- Lead DP vendor selection for new or alternative commercial suppliers.
- Develop and maintain relationships with contract manufacturers.
- Develop and maintain a resource- and budget-loaded DP manufacturing production timeline for near real-time tracking of production and resources.
- Coordinate periodic CMO manufacturing meetings (prepare minutes; track action items).
- Maintain and follow through a consolidated Acadia Manufacturing action log to ensure timely completion.
- Provide onsite process coverage as person-in-plant as needed.
- Develop and collect internal/external metrics to measure CMO and Acadia performance.
- Communicate manufacturing/technology issues and information to Manufacturing production team, TDO stakeholders, and project team.
- Supervise, train, and mentor personnel as needed.
- Prepare annual product reports with manufacturing CMOs.
- Schedule and coordinate steering committee meetings with CMOs and Acadia participants.
- Partner with Quality and Acadia Manufacturing SMEs to ensure quality events are managed, communicated, resolved, and closed; with Quality Assurance, ensure CMOs remain current and compliant with GMP requirements, guidelines, and procedures.
Education/Experience/Skills:
- BS, MS, or PhD in Engineering/Chemistry (or equivalent combination of relevant education and applicable experience).
- Minimum 12 years of progressively responsible experience in the pharmaceutical/biotechnology (or equivalent) industry.
Must possess:
- Contract service provider experience.
- Strong understanding of biopharmaceutical manufacturing, including regulatory filings and quality inspections/audits.
- Strong business acumen.
- Demonstrated experience preparing/reviewing annual product review/product quality review reports.
- Extensive knowledge of current cGMPs.
- Ability to operate effectively with urgency in a fast-paced environment.
- Outstanding communication: direct, effective, clear, concise, well organized, appropriate.
- Domestic and international travel required.
Physical Requirements:
- Regular standing, walking, sitting; use of hands for handling/operating equipment.
- May require reaching, climbing, balancing, stooping, kneeling, crouching; maintain visual/verbal/auditory communication.
- Occasionally lift/move up to 20 pounds.
- Ability to travel independently overnight and/or work after hours as needed.
Compensation/Benefits (as stated):
- Discretionary bonus and equity awards based on individual/organizational performance (amounts vary).
- Salary range: $174,100—$217,600 USD.
- Medical, dental, and vision insurance; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) with fully vested company match 1:1 up to 5%; Employee Stock Purchase Plan with 2-year purchase price lock-in.
- 15+ vacation days; 13–15 paid holidays (office closure Dec 24–Jan 1); 10 days paid sick time; paid parental leave; tuition assistance.
Locations:
- Princeton, NJ and San Diego, CA (seeking talent near these areas).
- Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMOs) and other third-party suppliers for identified products.
- Track ongoing manufacturing schedules to maintain commercial supply levels and meet inventory targets.
- Responsible for technical and business evaluation of the manufacturing network.
Primary Responsibilities:
- Lead and coordinate manufacturing activities across a matrix team; subject-matter expert in DP manufacturing, knowledgeable in development, quality, and regulatory requirements.
- Manage DP manufacturing: author/revise manufacturing documents (MBRs, Protocols, QRAs, etc.), oversee manufacturing operations, manage deviations and investigations, execute change actions, support product release, and ensure finished product arrives in warehouse for distribution.
- Lead DP vendor selection for new or alternative commercial suppliers.
- Develop and maintain relationships with contract manufacturers.
- Develop and maintain a resource- and budget-loaded DP manufacturing production timeline for near real-time tracking of production and resources.
- Coordinate periodic CMO manufacturing meetings (prepare minutes; track action items).
- Maintain and follow through a consolidated Acadia Manufacturing action log to ensure timely completion.
- Provide onsite process coverage as person-in-plant as needed.
- Develop and collect internal/external metrics to measure CMO and Acadia performance.
- Communicate manufacturing/technology issues and information to Manufacturing production team, TDO stakeholders, and project team.
- Supervise, train, and mentor personnel as needed.
- Prepare annual product reports with manufacturing CMOs.
- Schedule and coordinate steering committee meetings with CMOs and Acadia participants.
- Partner with Quality and Acadia Manufacturing SMEs to ensure quality events are managed, communicated, resolved, and closed; with Quality Assurance, ensure CMOs remain current and compliant with GMP requirements, guidelines, and procedures.
Education/Experience/Skills:
- BS, MS, or PhD in Engineering/Chemistry (or equivalent combination of relevant education and applicable experience).
- Minimum 12 years of progressively responsible experience in the pharmaceutical/biotechnology (or equivalent) industry.
Must possess:
- Contract service provider experience.
- Strong understanding of biopharmaceutical manufacturing, including regulatory filings and quality inspections/audits.
- Strong business acumen.
- Demonstrated experience preparing/reviewing annual product review/product quality review reports.
- Extensive knowledge of current cGMPs.
- Ability to operate effectively with urgency in a fast-paced environment.
- Outstanding communication: direct, effective, clear, concise, well organized, appropriate.
- Domestic and international travel required.
Physical Requirements:
- Regular standing, walking, sitting; use of hands for handling/operating equipment.
- May require reaching, climbing, balancing, stooping, kneeling, crouching; maintain visual/verbal/auditory communication.
- Occasionally lift/move up to 20 pounds.
- Ability to travel independently overnight and/or work after hours as needed.
Compensation/Benefits (as stated):
- Discretionary bonus and equity awards based on individual/organizational performance (amounts vary).
- Salary range: $174,100—$217,600 USD.
- Medical, dental, and vision insurance; employer-paid life, disability, business travel, and EAP coverage.
- 401(k) with fully vested company match 1:1 up to 5%; Employee Stock Purchase Plan with 2-year purchase price lock-in.
- 15+ vacation days; 13–15 paid holidays (office closure Dec 24–Jan 1); 10 days paid sick time; paid parental leave; tuition assistance.
Locations:
- Princeton, NJ and San Diego, CA (seeking talent near these areas).