Scientist I, Product Development

Scientist I, Product Development

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year.  The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates.  Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.

The Scientist I, Product Development contributes significantly to the successful timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying out required formulation and process activities. The Scientist I, Product Development supports new product development over the lifecycle of the project which could include benchtop/labscale, demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 

The Role

• Executes experimental studies intended to provide supporting data or to resolve technical issues encountered during each project.  Defines technical objectives and conveys them to other members of the project team.

• May represent the Softgel Product Development department at both internal team meetings and customer meetings relating to assigned projects that may be of diverse scope

• Coordinates with Analytical Services, Operations, QC, QA, and other groups to ensure project requirements are met.

• Resolves technical issues, makes recommendations for options that would resolve the issue, including a preferred option.

• Works independently, supervised on a daily or weekly basis, recognizes key issues likely to affect successful and/or timely completion.  For those issues that cannot be resolved, brings them to the attention of the person coordinating the work.

• Proposes and implements recommendations to processes and procedures designed to increase efficiency, safety or quality.

• Understands revenue associated with each project phase.  Flexible with respect to project priorities and ensures that site and/or departmental business objectives are met.

• Complete technical activities, development reports and regulatory support documentation

• Other duties as assigned.

The Candidate

• BS in scientific field with 5 plus years’ experience in lab, 3 in GMP OR

• MS in scientific field with 3 plus years’ experience in GMP lab OR

• Doctorate in scientific field with 1 plus years’ experience in lab.

• Working knowledge and application of scientific principles and techniques required.

• Familiarity with batch processing in a pharmaceutical, cGMP environment required.

• Attention to detail and high-level organizational skills required.

• Strong knowledge of cGMP Regulatory requirements for process development, technical transfer, and process changes required.

• Exposure to computer software associated with word processing and spreadsheets required with some exposure to statistical software preferred.

• Basic project management skills (deliverables, timelines, resources required) is preferred.

• Ability to work effectively under pressure to meet deadlines.  Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. 

• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far an