Project Manager

Project Manager

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 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 a Project Manager in Clinical Supplies. The Project Manager will work with our Clinical Services Supply site in San Diego and serves as a liaison between clients and 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 salaried position: Monday – Friday, 8:30am-4pm core hours (on-site). 

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:

• Evaluate, identify and develop continuous improvement to processes. Use technical expertise to successfully manage complex projects, mitigate risks and manage issues in timely manner. Development of clinical, stability, and commercial packaging protocols and materials. Develop strategic production plans and timelines. Lead discussions on strategic matters
• Advise clients in packaging and transportation strategic decision making. Ensure key project milestones are delivered timely with quality and integrity. Lead complex client communication. Host client on-site meetings, lead client teleconferences with agendas and meeting minutes and host internal/external project kick-off calls. Participate in internal or client audits
• Understand project contracts and client quality agreements, initiate amendments to both, and bill milestones in timely manner. Forecast M&P (Manufacturing and Production) revenue, and PM (Project Management) revenue to support S&OP (Sales and Operations Planning) and site forecast
• Will become proficient in JD Edwards (ERP), and perform all project set up entries and tracking as needed for all assigned projects and responsible for marking financial milestones. Will review contracts, investigate and propose solutions for disputed invoices to ensure timely resolution and payment
• Coordinate production preparation activities. Create and peer-review project source documentation with client input. Support creation of batch records based on project source documentation including primary, secondary labeling and kitting and assembly
• Develop, train and mentor Associate Project Managers and interact with cross functional teams to communicate project requirements and gather appropriate paperwork for batch records. Item Master identification and creator of request forms, JD Edwards Router, BOM (bill of materials), Purchase Order, and Work Order creation, Clinicopia, and GSA set up. Provide batch record training to production team on complex processes
• Support the creation of Change Orders and drive resolution to changes required during production through client collaboration. Obtain item numbers for labels and randomization copies for batch records
• Coordinate packaging, receiving and distribution activities, related