Project Manager

Project Manager (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 Project Manager (PM) for our Clinical Supply Services group will independently lead project teams in the management and successful delivery of assigned projects and client relationships. The Project Manager will be responsible for communicating with internal and external clients and working as an advocate for Catalent and clients alike. 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:

• Coordinate projects from award stage to completion ensuring correct planning timelines are generated, monitored and tracked to ensure successful adherence and completion. Accurately forecast M&P revenue, PM revenue, and supply chain to support S&OP and site forecast process
• Lead the implementation of new clinical and/or commercial projects including aspects of material qualification, master batch records, process validation, validation master plan and commercial supply agreements. Utilize and drive Smartsheet/Workfront timeline for day-to-day project activities and become proficient with JD Edwards ERP
• Attend and produce minutes and actions for client meetings/teleconferences/client visits and audits to support assigned projects or PM team and understand full scope requirements to generate all required project documentation
• When leading commercial projects, determine approach to be utilized, plan and help execute work independently with minimal supervision. Take a lead role in successful and timely launch and subsequent campaigns
• Receive, monitor and manage client supplied label text/randomizations, drug, components and materials and ensure delivery to internal functions as required. Generate required documentation and liaise with depot group for 3rd party depot set up
• Manage inventory reporting and monitor and track client inventory in line with project requirements. Set up clients on Fusion suite as required. Provide ongoing support for client use and password management. Set up returns phase of projects, generate, manage and monitor inventory reports and destruction process ensuring invoicing is completed
• Collect KPI data and provide to internal teams and client. Assist with departmental training and completion of training documentation. Will mentor junior project managers and project coordinators
• Will review contracts, investigate and propose solutions for disputed invoices, and effectively manage invoice queries to ensure timely resolution and payment. Assist in the preparation and regular review of Standing Operating Procedures relating to own areas of responsibility
• Other duties as assigned

The Candidate:

• Bachelor’s Degree and Project Management Professional (PMP) highly preferred. High School Diploma/GED required as a minimum
• One (1) year of customer service or client-facing PM role preferred, but ideally four (4) years or more within the pharmaceutical or clinical supply chain field
• Preferred experience in leading the initiation of projects in a cGMP regulated industry or validation experience with commercial pharmaceutical projects, knowledge of commercial supply agreements, validation master plans, process validation and rolling forecasts
• Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently

The anticipated salary range for this role in California is $95,000 to $105,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.  Catalent is a multi-state employer, and this salary range may not reflect positions that work in