Director, Manufacturing
Acadia Pharmaceuticals
1 month ago
Remote friendly (San Diego, CA)
United States
Operations
Position Summary:
Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMOs) and other third-party suppliers. Tracks ongoing manufacturing schedules to maintain commercial supply levels and meet inventory targets. Leads technical and business evaluation of the manufacturing network.
Primary Responsibilities:
- Lead manufacturing activities and coordinate across a matrix team; DP manufacturing SME knowledgeable in development, quality, and regulatory requirements.
- Manage all DP manufacturing activities: author/revise manufacturing documents (MBRs, Protocols, QRAs, etc.), oversee operations, manage deviations/investigations, implement change actions, support product release, and ensure finished product reaches warehouse for distribution.
- Own DP vendor selection for new or alternative commercial suppliers.
- Develop and maintain relationships with contract manufacturers.
- Develop and maintain resource- and budget-loaded DP production timelines for near real-time tracking.
- Coordinate periodic CMO manufacturing meetings; prepare minutes and track action items.
- Maintain and ensure follow-through on a consolidated Acadia manufacturing action log.
- 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 stakeholders and project teams.
- Supervise, train, and mentor personnel.
- Prepare Annual Product Reports with manufacturing CMOs.
- Schedule and coordinate Steering Committee Meetings with CMOs and internal participants.
- Partner with Quality/Manufacturing SMEs to manage quality events, ensure timely resolution/closure.
- With Quality Assurance, ensure CMOs remain current and compliant with GMP requirements, guidelines, and procedures.
Education/Experience:
- BS, MS, or PhD in Engineering/Chemistry (or equivalent education and experience).
- Minimum 12 years progressively responsible experience in pharmaceutical/biotechnology (or equivalent).
Required Skills/Qualifications:
- Contract service provider experience.
- Strong understanding of biopharmaceutical manufacturing, including regulatory filings, quality inspections, and audits.
- Strong business acumen.
- Experience preparing/reviewing Annual Product Review/Product Quality Review reports.
- Extensive knowledge of current cGMPs.
- Ability to operate effectively in a fast-paced environment with a strong sense of urgency.
- Outstanding communication (direct, clear, concise, organized).
- Domestic and international travel required.
Physical/Work Requirements:
- Ability to work in standard office environments (including remote), occasionally lift/move up to 20 lbs.
- Travel by car/air up to 30%; work after hours as required.
Compensation/Benefits (if applicable):
- Eligible for discretionary bonus and equity awards.
- Salary range: $174,100–$217,600 USD.
- Competitive base, bonus, and equity packages; medical/dental/vision; employer-paid life/disability/EAP and business travel; 401(k) match 1:1 up to 5%; ESPP; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance.
Responsible for business lead and coordination of commercial Drug Product Contract Manufacturing Organizations (CMOs) and other third-party suppliers. Tracks ongoing manufacturing schedules to maintain commercial supply levels and meet inventory targets. Leads technical and business evaluation of the manufacturing network.
Primary Responsibilities:
- Lead manufacturing activities and coordinate across a matrix team; DP manufacturing SME knowledgeable in development, quality, and regulatory requirements.
- Manage all DP manufacturing activities: author/revise manufacturing documents (MBRs, Protocols, QRAs, etc.), oversee operations, manage deviations/investigations, implement change actions, support product release, and ensure finished product reaches warehouse for distribution.
- Own DP vendor selection for new or alternative commercial suppliers.
- Develop and maintain relationships with contract manufacturers.
- Develop and maintain resource- and budget-loaded DP production timelines for near real-time tracking.
- Coordinate periodic CMO manufacturing meetings; prepare minutes and track action items.
- Maintain and ensure follow-through on a consolidated Acadia manufacturing action log.
- 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 stakeholders and project teams.
- Supervise, train, and mentor personnel.
- Prepare Annual Product Reports with manufacturing CMOs.
- Schedule and coordinate Steering Committee Meetings with CMOs and internal participants.
- Partner with Quality/Manufacturing SMEs to manage quality events, ensure timely resolution/closure.
- With Quality Assurance, ensure CMOs remain current and compliant with GMP requirements, guidelines, and procedures.
Education/Experience:
- BS, MS, or PhD in Engineering/Chemistry (or equivalent education and experience).
- Minimum 12 years progressively responsible experience in pharmaceutical/biotechnology (or equivalent).
Required Skills/Qualifications:
- Contract service provider experience.
- Strong understanding of biopharmaceutical manufacturing, including regulatory filings, quality inspections, and audits.
- Strong business acumen.
- Experience preparing/reviewing Annual Product Review/Product Quality Review reports.
- Extensive knowledge of current cGMPs.
- Ability to operate effectively in a fast-paced environment with a strong sense of urgency.
- Outstanding communication (direct, clear, concise, organized).
- Domestic and international travel required.
Physical/Work Requirements:
- Ability to work in standard office environments (including remote), occasionally lift/move up to 20 lbs.
- Travel by car/air up to 30%; work after hours as required.
Compensation/Benefits (if applicable):
- Eligible for discretionary bonus and equity awards.
- Salary range: $174,100–$217,600 USD.
- Competitive base, bonus, and equity packages; medical/dental/vision; employer-paid life/disability/EAP and business travel; 401(k) match 1:1 up to 5%; ESPP; 15+ vacation days; 13–15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance.