Pharmaceutical Project Manager

Catalent Pharma Solutions•St. Petersburg, FL

11d•Onsite

About The Position

The Pharmaceutical Project Manager is the primary customer-facing leader for assigned CDMO clients, managing projects from pre-clinical development through Phases I–IV and lifecycle management. The role is on-site at Catalent’s St. Petersburg, Florida site, a flagship Softgel development and manufacturing facility in North America. The Project Manager is accountable for customer satisfaction, timely clinical delivery, revenue forecast and budget adherence, and effective cross-functional execution. Work must comply with cGMP, regulatory, quality, and safety standards in a global, FDA-regulated CDMO environment. The role includes coordinating and conducting phase gate reviews and approvals before clinical manufacturing for each development phase and/or before registration, validation, and major regulatory changes. Other duties may be assigned.

Requirements

Bachelor’s degree required.
At least 5 years of industry experience required.
Working knowledge of project management principles and concepts in a cGMP environment required.
At least 2 years of project management experience, or other experience demonstrating successful team leadership and project management acumen.
PC skills and training in Microsoft Project, Outlook, Excel, Word, PowerPoint, WorkFront, and other Catalent software packages required.
Ability to sit, stand, and walk regularly; occasionally lift up to 15 pounds; and not lift more than 40.09 pounds without assistance.
Ability to access the manufacturing floor and office staff and use required office equipment.
Vision sufficient to read written documents and frequently use a computer monitor.

Nice To Haves

Bachelor’s degree preferably in a scientific field, including Chemistry, Biology, Pharmacy, Chemical Engineering, or Mechanical Engineering.
Industry experience preferably in the pharmaceutical industry, and most preferably with an FDA-regulated CDMO company.
PMP certification preferred.

Responsibilities

Serve as the single point of contact for assigned CDMO clients.
Manage client relationships, including hosting site visits, governance meetings, and routine project updates.
Monitor customer satisfaction and address risks and escalations as needed.
Provide clear, timely, and professional communication to customers throughout the project lifecycle.
Follow up on decisions, risks, and deliverables in a timely manner.
Escalate critical-path issues that affect schedule, cost, quality, or compliance.
Coordinate and conduct phase gate reviews and approvals before clinical manufacturing for each development phase and/or before registration, validation, and major regulatory changes.
Ensure customer satisfaction, timely clinical delivery, adherence to revenue forecast and budget, and effective cross-functional execution while maintaining applicable cGMP, regulatory, quality, and safety standards.
Perform other duties as assigned.