Supervisor, Operations Project Lead

Supervisor, Operations Project Lead (OPL)

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 hiring a Supervisor, Operations Project Lead (OPL). The Supervisor, Operations Project Lead is responsible for overall management of the operation project lead team. The OPL team is responsible for facilitating the tech transfer of R&D processes at development scale to GMP scale. This includes master batch record generation, label specification generation, GMP material readiness, and equipment coordination. The OPL team works in partnership with all operations departments to coordinate GMP readiness. The OPL team is responsible for the oversight of GMP manufacturing and acts as liaison of the GMP manufacturing teams to internal departments (product development, process engineering, project management) and external clients. This individual will lead, develop, and oversee the OPL team and must demonstrate excellent leadership, communication, critical thinking, and organizational skills. The Supervisor, Operations Project Lead will drive to meet objectives efficiently and on time and will maintain oversight of all GMP production activities.

This is a full-time salaried position on-site : Monday Friday, day shift hours (1st shift).

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 :

• Supervision of direct reports, including managerial responsibilities such as the allocation of resources, organization of projects and performance reviews. Provide leadership and functional job training for Operations Project Lead (all levels), including professional development and staff recognition
• Direct communication with client contacts for all projects maintained by direct reports, including the handling of issues or sensitive subjects that arise. Host clients on-site / lead client meetings / conference calls. Support Business Development by providing technical expertise, support regarding timelines
• Lead or manage pre-production planning activities - Facilitate Manufacturing (MFG) tech transfer meetings with Product Development and Process Engineering
• Collaborate with Manufacturing, Product Development, Process Engineering, Project Management personnel and clients to co-managing cGMP runs. Participating in group meetings, inter- and intra-department meetings, conference calls and interactions with clients with minimal assistance from the department head
• Generation and review of manufacturing batch records, manage Catalent San Diego Master Batch Record modules
• Responsible to be on-site for manufacturing activities. Provide troubleshooting support in MFG suites. OPL team is liaison for communication of MFG activities to internal departments and clients
• Provide supervisor level signoff of events and deviations prepared by Manufacturing Coordinators (all levels) and collaborate with QA and Operations Management on root cause and CAPA plans. Perform root cause analysis, address production issues and generate production deviations and address product related complaints, when applicable
• Other duties as assigned

The Candidate :

Pay :

Why you should join Catalent :

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.