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An established industry player is seeking a Pre-Production Specialist to manage Fast Chain Assembly Orders and batch records. This role involves collaboration with various departments to ensure accurate order processing and compliance with SOPs. The ideal candidate will have strong attention to detail, excellent communication skills, and the ability to work effectively under pressure. Join a dynamic team committed to improving lives through innovative drug development and delivery, and be part of a company that values personal initiative and meaningful work.
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.
The Candidate
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.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.