Project Management Coordinator

Catalent • Saint Petersburg, FL

9d • Onsite

About The Position

The St. Petersburg facility is North America's primary softgel development and manufacturing site, equipped with a dedicated pilot plant for lipid formulation development and rapid transition from lab scale to clinical supply. It also offers liquid-in-bottle and liquid-fill hard-shell capabilities to expedite speed to clinic. Within the Catalent network, the site provides integrated formulation and analytical services to address complex development and manufacturing challenges. The analytical laboratory offers comprehensive services, from method development to routine QC testing, supporting commercial and development stability studies. With an annual capacity of over 18 billion softgels and serving over 100 global markets, the St. Petersburg site can handle manufacturing needs for Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement products. The facility includes a segregated hormone manufacturing area compliant with current regulatory requirements. In addition to traditional animal-based gelatin softgels, the site produces products in non-gelatin based OptiShell® and Vegicaps® to broaden the range of encapsulatable molecules.

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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level