Acadia Pharmaceuticals seeks a Senior Manager, Packaging and Serialization to oversee commercial Drug Product Contract Manufacturing organizations (CMO’s) and third-party suppliers for products as identified. The ideal candidate will have experience in serialization, package design, and local requirements for product introduction into the EU and other global markets.
Requirements
- Develops and maintains good working relationships with both internal stakeholders and contract manufacturers.
- Acquires and maintains scientific and technological knowledge and background of existing and new pharmaceutical (surface) serialization technologies to ensure our CMOs are aligned.
- Verifies CMO serialization technologies and ensures compliance with pharmaceutical regulatory requirements (EU FMD and DSCSA).
- Coordinate 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.
- Work with CMOs and Acadia participants to schedule and coordinate Steering Committee Meetings.
- Works with Quality Group and Acadia 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.
- Provide 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.
Benefits
- Competitive base salary
- Discretionary bonus
- Equity awards
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
