Associate Project Lead, Pre-Production

Associate Project Lead, Pre-production (Clinical Supply)

Position Summary:

• Work Schedule: Monday-Friday, core hours 8am-4:30pm
• 100% on-site (San Diego)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent’s West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution.

The Associate Project Lead (PL) will support pre-production teams in the management and successful delivery of assigned Projects for our Clinical Supply site. The Associate Project Lead serves as a liaison between cross functional teams to ensure project success while complying with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). Primary responsibilities of this position include activities related to supply chain, procurement, batch record and label creation, and other project management and coordination activities affiliated with assigned projects. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients.

The Role:

• Development of clinical, stability, and commercial packaging protocols and materials. Develop strategic production plans and timelines. Lead discussions on strategic matters
• Attend client meetings and produce minutes and actions for internal client meetings/teleconferences/client visits and audits to support PL team and understand full scope requirements to generate all required project documentation. Ensure key project milestones are delivered timely with quality and integrity. Generate required documentation and liaise with clients as needed
• Will become proficient in Enterprise Resource Planning (ERP) system JD Edwards, and perform all project set up entries and tracking as needed for all assigned projects and responsible for marking financial milestones
• Coordinate production preparation activities. Create batch records based on project source documentation including primary, secondary labeling and kitting and assembly. Interact with cross functional teams to communicate project requirements and gather appropriate paperwork for batch records. Provide batch record training to production team on complex processes
• Item Master identification and creator of request forms, JD Edwards Router, Bill of Materials (BOM), Purchase Order, and Work Order creation, Clinicopia, and GSA set up. Create Change Orders and drive resolution to changes required during production. Obtain item numbers for labels and randomization copies for batch records. Support Label proof design and label printing
• Coordinate packaging, receiving and distribution activities, related to item master requests, zero-dollar purchase order generation, shipment request completion. Support procurement activities of needed project materials in timely, efficient and cost-effective manner. Support material onboarding for vendor-procured and client-supplied materials
• Understand and adhere to standard operating procedures (SOPs) in a GMP setting. Support service complaint investigations
• Other duties as assigned

The Candidate:

• High School Diploma/GED is required with a minimum of one (1) year of relevant experience in clinical supply, project management, or pharmaceutics. We will also accept a Bachelor’s degree with no experience, but candidates with one year of GMP technical writing and/or packaging experience are highly preferred
• Experience with preparation of batch records, packaging, labeling, assembly, supply chain, procurement and distribution of clinical trial materials, pharmaceutical/biotech environment is preferred
• Thorough knowledge of systems is preferred – JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS (Electronic Document Management System), etc.
• Excellent written and verbal communication skills for client communication and exceptional internal and external customer service skills is required. Proactive, with superior time management, organizational skills, and detailed oriented. Able to prioritize, manage multiple tasks and stressful situations. Able to work independently, as a team, motivate cross functional teams to meet deliverables on time. Problem solvin