Senior Scientist, 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 Senior Scientist, 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 Senior Scientist is part the Product Development team that is responsible for new product development over the lifecycle of the project which could include benchtop/lab scale, demonstration/feasibility batches, registration/stability batches, and technical support of process validation batches. Addition responsibilities may include support of development/commercial product investigations, and technology transfers from other sites to the St. Petersburg, FL facility.  The group is also responsible for Gap Assessments, Risk Assessments, and the implementation of process analytical technology (PAT) solutions and overall support of all aspects of product development.

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 (including other technologies).

• 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, recognize 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.

• Propose and implement 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.

• Completes technical activities, development reports and regulatory support documentation as required.

• Maintains an awareness of current scientific practice that may have a relevance to Catalent Pharma Solutions

• Maintains current training records for required procedures. Assists in the training, development, and evaluation of any Softgel Formulation personnel when required.

• Other duties as assigned.

The Candidate

• PhD in Pharmacy/Pharmaceutical Sciences, Engineering, or related science with 3+ years of applicable product development experience required and 1+ years of direct softgel product development experience preferred.  Pre-formulation and early formulation development experience highly preferred.

• MS/BS in Pharmacy/Pharmaceutical Sciences, Engineering, or related science with 7+ years of applicable product development experience and 1+ years of direct softgel product development experience preferred.  Pre-