Senior Manager, Packaging and Serialization

Role Summary

Senior Manager, Packaging and Serialization – responsible for coordinating packaging (package design), artwork, and serialization with contract manufacturing organizations (CMOs) and other third-party suppliers near Princeton, NJ or San Diego, CA. Serves as the subject matter expert in serialization to oversee CMOs handling commercial products and Acadia data management and integration. Experienced in the technical aspects of introducing products into the EU and other global markets related to serialization and packaging requirements.

Responsibilities

• Develops and maintains good working relationships with internal stakeholders and contract manufacturers.
• Acquires and maintains scientific and technological knowledge of existing and new pharmaceutical serialization technologies to ensure CMOs are aligned; verifies CMO serialization technologies and ensures compliance with regulatory requirements (EU FMD and DSCSA).
• Coordinates periodic CMO manufacturing meetings, prepares minutes, and tracks completion of action items.
• Maintains and follows through a consolidated Acadia Manufacturing action log to ensure all manufacturing-related actions are completed on time.
• Works 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 for timely resolution and closure.
• With Quality Assurance, ensures CMOs remain current and compliant with GMP-related requirements, guidelines and procedures.
• Provides onsite process coverage as needed.
• Develops and collects internal and external metrics to measure CMO and Acadia performance.
• Communicates manufacturing or technology-related issues to Manufacturing production team members, department stakeholders, and other project team members.
• Supervises, trains, and mentors personnel as needed.

Qualifications

• Minimum of 8 years of progressively responsible experience within the pharmaceutical/biotechnology or equivalent industry.
• Contract service provider experience.
• Strong understanding 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.
• Experience in a cGMP environment.
• Capability to communicate efficiently and effectively about issues of a complex (technological and scientific) nature.
• Attention to detail.

Education

• BS in Engineering/Chemistry or equivalent combination of relevant education and applicable job experience. Scientific advanced degree a plus.

Additional Requirements

• Domestic and International travel is required for this role.
• Physical requirements: Regularly stand, walk, sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. May lift and/or move up to 20 pounds. Travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.