Senior Manager, Packaging and Serialization

Role Summary

Responsible for coordination of packaging (package design), artwork, and serialization with contract manufacturing organizations (CMOs) and other third-party suppliers. Serves as the subject matter expert in serialization to oversee Acadia CMOs’ data management and integration. Experienced with the technical aspects of introducing products into the EU and other global markets as related to serialization, packaging, and local requirements. Location: Princeton, NJ or San Diego, CA.

Responsibilities

• 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.

Education

• BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. Scientific advanced degree a plus.
• A minimum of 8 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.

Qualifications

• Contract service provider experience.
• Strong understanding is required of the biopharmaceutical serialization and packaging process
• Demonstrated experience with preparing/reviewing annual product review/product quality review reports.
• Extensive knowledge of current Good Manufacturing Practices (cGMPs)
• Able to operate effectively and with a strong sense of urgency in a fast-paced environment.
• Outstanding communicator: direct, effective, clear, concise, well organized and appropriate.
• Domestic and International travel is required for this role.
• Experience in a cGMP environment
• Capability to communicate efficiently and effective about issues of a complex (technological and scientific) nature
• Attention for detail

Skills

• Serialization and packaging process knowledge
• Experience coordinating with contract manufacturers (CMOs) and cross-functional teams
• Regulatory awareness (EU FMD, DSCSA) and cGMP familiarity
• Effective communication and leadership abilities
• Managing meetings and action-item tracking
• Data management and metrics development for CMO and program performance

Additional Requirements

• Domestic and international travel required (up to 25% of the time)
• Ability to travel by car or airplane independently
• Physical requirements: ability to stand, walk, sit, use hands and fingers, reach, climb/balance, stoop/kneel/crouch, see, hear; lift up to 20 pounds