Pre-production Specialist, Global Operations

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.

We are looking to recruit a** Pre-Production Specialist** to join our team. The role of **Pre-Production Specialist** is to manage the Fast Chain Assembly Orders and batch records within the SFX system for the global network.

The **Pre-Production Specialist** will work with Strategic Supply Solutions, Clinical Excellence Operations, Global Operations, and site specific departments including but not limited to Project Management, Pre-Production,

Operations and Quality in the US, UK, EU, and APAC to receive client order details and convert into a standardized format, adding required supplemental data and site specific needs and aggregating them into executable orders and batch records for all sites involved in the study.

This is a site based position.

**The Role**
- Create site packaging and/or shipment orders
- Perform study set up, design and writing of the batch records
- Manage client demand received via various data exchange methods to ensure all orders are received and processed in a timely manner to prevent patient risk
- Review and audit assembly order & shipment order packets for accuracy.
- Check availability and select bulk material to order within SupplyFlex Aggregator
- Generate assembly & shipment orders for the requested Clinical Trial Materials in SupplyFlex Aggregator to meet client demand in line with protocol specific service levels and turnaround times
- Execute the manual business continuation process in the event of a SupplyFlex outage
- Using Excel & Clinicopia, assign kit numbers to orders and shipments if not client provided
- Manage aggregation execution and monitor requesting patterns to flag required changes to the schedule
- Ensure that created assembly and shipment orders are in compliance with all applicable SOPs and in accordance with Packaging and Distribution information (PADI) and audit request packets for accuracy.
- Good level of education
- High level attention to detail while managing multiple projects and/or priorities under tight deadlines
- Proven written, verbal, and interpersonal communication skills are required.
- Fluent in English both written and spoken
- Ability to work effectively and efficiently under pressure to meet competing workplace demands and appropriately prioritize is required
- Strong organizational skills are required
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form is required
- Ability to work on own initiative
- Effective communicator, logical thought processes and investigative skills
- Strong computer skills are required - (including, but not limited to, SupplyFlex, Supplyflex Aggregator, Clinicopia, Microsoft Excel, JDE, GSA, SharePoint and ability to quickly learn new systems/programs)
- The role can be located within commutable distance to our offices in Singapore, China or Japan.

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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