Project Manager
The Project Manager will serve as the primary customer-facing leader responsible for managing end-to-end CDMO client projects across the full product lifecycle, from pre-clinical development through Phases IāIV and lifecycle management.
Position Summary
This position is on-site at the St. Petersburg site.
Join Catalentās flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive pay, day-one benefits, and career growth in a state-of-the-art, turn-key facility.
The Project Manager is responsible for ensuring customer satisfaction, timely clinical delivery, adherence to revenue forecast and budget, and effective cross-functional execution, all while maintaining compliance with cGMP, regulatory, quality, and safety standards required in a global, FDA-regulated CDMO setting.
The Role
Serve as the single point of contact for assigned CDMO clients.
Manage client relationships, including hosting site visits, governance meetings, and routine project updates.
Proactively monitor and manage customer satisfaction (ācustomer temperatureā), addressing risks and escalations as needed.
Provide clear, timely, and professional communication to customers throughout the project lifecycle.
Ensure timely follow-up on decisions, risks, and deliverables.
Escalate critical path issues impacting schedule, cost, quality, or compliance.
Coordinate and conduct phase gate review and approval prior clinical manufacturing for each development phase and/or prior registration, validation, and major regulatory changes.
All other duties as assigned.
The Candidate
Bachelorās degree is required; preferably in a scientific field, including, but not limited to, Chemistry, Biology, Pharmacy, Chemical and Mechanical engineering with at least 5 years of industry experience is required; preferably in the pharmaceutical industry, and most preferably with an FDA-regulated CDMO company.
Working knowledge of project management principles and concepts in a cGMP environment is required.
At least 2 years of project management experience or other experience that demonstrates successful team leadership and project management acumen.
PMP certification is preferred.
PC skills, including training on Microsoft Project, Outlook, Excel, Word, PowerPoint, WorkFront and other Catalent software packages are required.
Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 40.09 pounds without assistance.
Be accessible to manufacturing floor and office staff and to use required office equipment.
Specific vision requirements include reading of written documents and frequent use of computer monitor.
Why You Should Work At Catalent
Spearhead exciting and innovative projects
Fast-paced, dynamic environment
High visibility to members at all levels of the organization
152 hours of PTO + 8 paid holidays
Catalent offers rewarding opportunities to further your career!Ā 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.Ā
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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