Product Development Group Leader

Product Development Group Leader

Position Summary

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug 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 Product Development Group Leader will lead projects and innovations as well as builds and leads a team focused on the development and characterization of oral solid dosage products. The primary formulation platforms include tablets, capsules, and immediate release and extended-release dosage forms. The Product Development Group Leader researches and introduces new formulation technology to produce and characterize drug products and will be the primary point of client contact for formulation strategy, compliance, and troubleshooting. The position supports department initiatives, evaluates new technologies to expand site service offerings, and ensures overall timelines and client expectations related to pharmaceutical projects are met.

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.

The Role

• Provide technical leadership and oversight of formulation and process development activities within group.

• Responsible for GMP compliance in all aspects of batch manufacturing and documentation.

• Create and develop innovative drug formulations.

• Perform and train others on a variety of formulation techniques including, but not necessarily limited to: blending, encapsulation, wet/dry/fluid bed granulation, tablet compression, coating, milling, and multiparticulates.

• Perform and train others on a variety of characterization techniques related to powder and dosage form development, including but not limited to, bulk/tap density testing, sieve analysis, and more advanced techniques including powder rheometry, solid fraction, and advanced techniques such as SEM and compaction simulation.

• Responsible for transfer of projects to external manufacturers, or late stage/commercial manufacturing team at the local site and other sites within the company.

• Stay abreast of current scientific technologies to maintain the state-of-the-art nature of our services and will evaluate new technologies to expand our technical service offering.

• Provide input to Commercial Operations and Project Management for new business development, including service estimate generation, due date assignments, and revenue recognition for group activities.

• All other duties as assigned.

The Candidate

• Bachelor’s degree in Pharmacy, Chemistry, Biology or related field with at least 9 years of experience in drug product development or;

• Master’s in Pharmacy, Chemistry, Biology or related field degree with at least 7 years of experience in drug product development or;

• PhD in Pharmacy, Chemistry, Biology or related field with at least 4 years of experience in drug product development.

• At least 5 years of oral solid dosage pharmaceutical experience.

• At least 3 years of leadership experience with demonstrated management skills (e.g. business knowledge, leadership, communication, ability to analyze technical issues, conflict resolution) and ability to motivate employees.

• Thorough knowledge of cGMPs and other government regulations appropriate to pharmaceutical manufacturing.

• Majority of work day is performed while sitting, sta