Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
SUMMARY OF ESSENTIAL FUNCTIONS
Coordination of activities required to complete the pre-production elements of project execution. To function as the main point of contact and the link between Project Management and Operations in all Secondary Packaging activities.
The Role:
- Creation of accurate Packaging Designs that reflect the needs of the client and meet GMP requirements
- Ensure appropriate QIFs are raised in the event that final Pack Designs differ from the original contract
- Support Procurement with approved vendors to purchase required packaging components, label stock and equipment in a timely manner to fulfil Production timelines
Work with the Project Management team to ensure good understanding of the project(s) and that all client required documentation is received and approved in a timely manner e.g. Label Approvals, SBI/SBOM, XBR- Work with the Centre of Excellence for Label Printing (Catalent SHA) to organize the set-up of new labels within the label printing system accurately. Proactively assess label stock considerations and label design to ensure Right First-Time set-up.
- Creation of accurate packaging and labeling documentation to meet the needs of both the client and regulatory GMP requirements including Label Print Forms (LPFs) and Batch Records (Supplyflex)
- Set-up packaging configurations and packaging jobs within Global Scan Assembly
- Support Packaging Execution (Traditional, FastChain) as needed
- Support Label Printing as needed
- Support Executed Batch Record Review
- Support Trackwise investigations, reporting and CAPA implementation
- Review and maintain Production Schedule – ensuring requested jobs are fulfilled per required timelines and any foreseeable delays are escalated for resolution.
- Drive Continuous Improvement projects within Operations (process and training initiatives)
- Lead coordination and communication with internal and external stakeholders for urgent and ad hoc requests
- Provide troubleshooting support and drive issue resolution.
- Support JDE Troubleshooting; cancellations and corrections
- Participate in Study Kick Off Meetings and support operational set-up activities
The Candidate:
Education and Experience:
- Pharmaceutical Packaging and Logistics experience
- Packaging design experience
- Strong written, verbal, and interpersonal communication skills with the ability to communicate effectively across all levels of the organization.
- Critical thinker, problem solver – continuous improvement mindset. Able to work in a fast-paced environment, with high attention to detail
Knowledge/Skill Requirements:
- Stakeholder management
- Strong computer and organizational skills are required
- Knowledge of inventory management systems