Pre-Production Specialist
About The Position
Catalent’s San Diego, CA site is an early‑phase development facility supporting small‑molecule and peptide programs from preformulation through cGMP clinical manufacturing for oral and injectable dosage forms. The 68,000‑square‑foot site is a center of excellence for spray‑drying and bioavailability‑enhancement technologies, with integrated capabilities to advance challenging compounds rapidly into the clinic. We have an opportunity for a Pre-Production Specialist to join our team. In this role, you will manage Fast Chain Assembly Orders and batch records within the SFX system for the global network. You will create site packaging and shipment orders using SupplyFlex Aggregator and perform study setup, design, and writing of batch records. This position involves working closely with global teams and site-specific departments to ensure accurate and timely preparation of client orders for production. Shift: Monday to Friday 8am-4:30pm Location: San Diego or Kansas City 100% Onsite
Requirements
- High School Diploma or General Education Diploma and at least 10 years of Pharmaceutical Packaging experience
- High attention to detail while managing multiple projects and priorities under tight deadlines
- Strong computer skills, including SupplyFlex, SupplyFlex Aggregator, Prisym, Microsoft Excel, JD Edwards, GSA, SharePoint, and ability to learn new systems
- Strong organizational skills
- Proven written, verbal, and interpersonal communication skills
- Ability to work effectively under pressure, prioritize tasks, and meet competing demands
- Ability to interpret instructions in written, oral, diagram, or schedule form
- Ability to work independently
- Effective communication, logical thinking, and investigative skills
Nice To Haves
- Bachelor’s Degree and 3 years of Pharmaceutical Packaging experience preferred
Responsibilities
- Manage client demand received via various data exchange methods to ensure timely processing and prevent patient risk
- Review and audit assembly and shipment order packets for accuracy; check availability and select bulk material within SupplyFlex Aggregator
- Generate assembly and shipment orders for Clinical Trial Materials in SupplyFlex Aggregator to meet client demand and service levels
- Execute manual business continuation process during SupplyFlex outages
- Assign kit numbers using Excel and Clinicopia when not provided by the client
- Collaborate with PM, PGM, and GBO during study setup to create aggregation schedules and provide feedback on PADIs
- Manage aggregation execution and monitor patterns to identify schedule changes
- Identify and resolve supply chain issues, reporting findings to relevant stakeholders
- Ensure compliance of assembly and shipment orders with SOPs and Packaging and Distribution Information (PADI)
- Attend global project kick-off meetings to gather information for study setup and XBR tasks
- Coordinate study setup requirements with Production, Quality Assurance, Label Control, and Packaging Design/Engineering
- Identify required Item Numbers and submit requests to MDM
- Generate Study Setup parts in collaboration with all involved sites and global MDM
- Ensure regulatory differences are considered in study setup and included in SBI and SBOM
- Create executable batch records based on project documentation, including labeling, kitting, and assembly
- Create JD Edwards Router, BOM, Purchase Order, and Work Order
- Perform setup of GSA and Clinicopia
- Communicate with clients to address questions and provide required documentation
- Manage multi-site prioritization and workload distribution to meet client deliverables
- Support project timelines to ensure milestones are met and deliver packaging documentation on time
- Other duties as assigned
Benefits
- Competitive Paid Time Off plus 10 paid holidays
- Medical, dental, and vision benefits effective day one
- Tuition Reimbursement to support your education goals
- Engaging site-based activities such as Movie Day, Annual Blues Fest, and Free Bagel Fridays
- Employee Resource Groups promoting Diversity and Inclusion
- Green initiatives and community engagement, including beach clean-ups
- Defined career path with annual performance reviews and growth opportunities
- WellHub program promoting physical wellness, including onsite fitness center and yoga classes
- Exclusive discounts through Perkspot from over 900 merchants
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
