Project Manager

Catalent Pharma SolutionsSan Diego, CA
15d$95,000 - $105,000Onsite

About The Position

Project Manager (Clinical Supply) Position Summary: Work Schedule: Monday-Friday, core hours 8:00am-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.

Requirements

  • Bachelor’s Degree required
  • Minimum of 2 years of customer service or client-facing project management experience required; 4 or more years of experience within the pharmaceutical or clinical supply chain field preferred.
  • Superior time management and organizational skills, adopting a committed approach to providing a high level of customer service required
  • Strong communication skills (written and verbal) with demonstrated professionalism, positive attitude, and client‑facing experience; able to work collaboratively in a team environment with a right‑first‑time mindset and commitment to meeting deadlines.
  • Working knowledge of commercial supply agreements, validation master plans, process validation, rolling forecasts, and related IT systems (experience authoring these documents is a plus).

Nice To Haves

  • Professional project management qualification (e.g., PMP) is preferred.
  • Experience leading the initiation of projects in a cGMP regulated industry or validation experience with commercial pharmaceutical projects is desired.

Responsibilities

  • 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

Benefits

  • Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
  • Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
  • Defined career path and annual performance review and feedback process.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • Several Employee Resource Groups focusing on Diversity and Inclusion.
  • Competitive salary with bonus potential.
  • Generous 401K match and Paid Time Off accrual.
  • Medical, dental and vision benefits effective day one of employment.
  • 152 hours of PTO + 10 paid holidays.
  • Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
  • Tuition Reimbursement – Let us help you finish your degree or earn a new one!
  • WellHub program to promote overall physical wellness.
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
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