Project Management Coordinator

Project Management Coordinator

About Site

St. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St. Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.

Position Summary

We have an opportunity for a Project Management Coordinator to join our team. In this role, you will support the delivery of customer requests and ensure all project deliverables are achieved on time. You will work closely with scientists and project management to compile regulatory documentation and maintain readiness to execute. This position plays a key role in supporting operations, quality, and cross-functional collaboration to ensure successful project outcomes.

Shift: Standard Hours, Monday through Friday
Location: St. Petersburg, FL
100% Onsite

The Role

• Deliver customer requests and ensure deliverables are attained in support of readiness to execute (RTE).
• Work closely with scientists and project management to ensure on-time delivery of requested documentation.
• Support customer regulatory documentation compilation and follow up on document change requests to ensure timely execution within project timelines.
• Facilitate deliverables required to ensure readiness to execute (RTE) and support operations with all required documents for batch manufacture.
• Support the Quality Unit to ensure all required documents are in place to support batch release.
• Define and continuously improve key processes; escalate delayed deliverables to Project Management due to priority conflicts or other reasons.
• Collaborate cross-functionally to translate Product Development milestones and effectively communicate with various levels within the organization.
• Learn and utilize Quality, Project Management, procurement, and supply chain systems to monitor documentation, project timelines, and logistics; take ownership of assignments, improve processes, and support special projects or smaller projects as assigned.
• Other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor’s Degree required.
• Proficient knowledge of Microsoft programs required (Excel, Word, Access, and PowerPoint).
• Ability to work effectively under pressure to meet deadlines. Individual required to sit, stand, walk, and lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance. Must be accessible to manufacturing floor and office staff and use required office equipment. Specific vision requirements include reading written documents and frequent use of a computer monitor screen.

Preferred Skills & Background

• Demonstrated project management experience is a plus.
• Experience in FDA regulated industry or the pharmaceutical CDMO industry is a plus.
• Knowledge of Microsoft Projects and ability to understand timelines is preferred.
• Experience in technical writing and change control is preferred.
• Knowledge of Documentum, TrackWise, and JD Edwards preferred.
• Working knowledge of Pharmaceutical and Biotech industries is desired.
• Working knowledge of Project Management is desired.

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement – support to finish your degree or earn a new one.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly, community engagement green initiatives including regular participation in Beach Clean-up.
• Defined career path and annual performance review and feedback process with potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• WellHub program to promote overall physical and mental wellness.
• Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

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.

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