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 inventory targets. Leads technical and business evaluation of the manufacturing network.
Primary Responsibilities:
- Lead DP manufacturing activities; coordinate across a matrix team; act as SME for DP manufacturing including development, quality, and regulatory requirements.
- Manage DP manufacturing: author/revise manufacturing documents (MBRs, protocols, QRAs, etc.), oversee operations, manage deviations/investigations and change actions, support product release, and ensure finished goods reach the warehouse for distribution.
- Lead DP vendor selection for new or alternative suppliers; maintain relationships with contract manufacturers.
- Build and maintain resource-/budget-loaded production timelines for near real-time tracking.
- Coordinate periodic CMO manufacturing meetings; capture minutes and track action items.
- Maintain a consolidated manufacturing action log to ensure timely completion.
- Provide onsite process coverage as needed.
- Develop and collect internal/external metrics to measure CMO and Acadia performance.
- Communicate manufacturing/technology issues and information to stakeholders.
- Supervise, train, and mentor personnel.
- Prepare Annual Product Reports with CMOs.
- Schedule/coordinate Steering Committee Meetings with CMOs and internal participants.
- Partner with Quality and QA to ensure Quality Events are managed and closed; ensure CMOs remain compliant with GMP requirements.
Education/Experience/Skills:
- BS/MS/PhD in Engineering or Chemistry (or equivalent); minimum 12 years progressively responsible pharma/biotech experience.
Must have:
- Contract service provider experience.
- Strong biopharmaceutical manufacturing knowledge (regulatory filings, quality inspections, audits).
- Strong business acumen; experience with annual product quality review/report preparation.
- Extensive cGMP knowledge; urgency in a fast-paced environment.
- Excellent communication (direct, clear, concise, organized).
- Domestic and international travel required.
What we offer:
- Competitive base salary; eligible for discretionary bonus and equity.
- Salary range: $173,000β$216,200 USD.
- Medical, dental, vision; employer-paid life/disability/business travel/EAP.
- 401(k) match 1:1 up to 5%; employee stock purchase plan; 15+ vacation days; 13β15 paid holidays; 10 days paid sick time; paid parental leave; tuition assistance.