Associate Project Lead, Pre-Production

Associate Project Lead, Pre-production

Position Summary:

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. 

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services.  At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best.

Catalent Pharma Solutions is San Diego, CA is hiring an Associate Project Lead (PL) that 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). The focus will be on understanding client needs and providing excellent customer service and proactive solutions. 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.

This is a full-time hourly position on-site: Monday – Friday, 8am-4pm with periodic flexibility in work hours.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

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: