Catalent
Pharmaceutical
DevelopmentScientistII
Neural analysis suggests this role is
optimal for Senior candidates.
“Development Scientist II at Catalent. Skills: Formulation development, Process development, Project management, Customer contact. Support pharmaceutical development. Support clinical trial batch manufacturing”
Industry & Context.
Solving formulation problems; Solving process problems
Exposure to hazardous chemicals, Exposure to active chemical ingredients, Requires respirator use
What They're Looking For.
Must Have
Bachelor’s degree in Pharmacy, Chemistry, Biology or related field with eight or more years of experience in pharmaceutical development with focus on solids formulation required, Master’s degree in Pharmacy, Pharmaceutics, Industry Pharmacy, or related field with six or more years of experience in pharmaceutical development required, Ph. D. in Pharmacy, Pharmaceutics, Industry Pharmacy or related field with four or more years of experience in pharmaceutical development required, GMP compliance in formulation and process development, Ability to handle and manipulate objects using hands and arms, Ability to occasionally lift items in excess of 50 pounds, Ability to complete a medical evaluation for respirator use
What You'll Do.
Support pharmaceutical development
Support clinical trial batch manufacturing
Support packing and documentation
Oversee formulation and process development
Manage customer projects
Solve formulation problems
Solve process problems
Write IQ/OQ/PQ documents
Write development reports
Write technical reports
How You'll Work.
Team & Collaboration
Work directly with customers; Work with potential customers; Assist manufacturing group
Communication Scope
Customer contact
Process & Methodology
Project management, Customer contact, Agree on development approaches, Agree on scope of work
Full Job Description
**Development Scientist II** The Development Scientist II serves as a primary point of contact with the client regarding pharmaceutical development and clinical manufacturing project related activities. The Development Scientist II is responsible for supporting these activities in the areas of supervision, process development, clinical trial batch manufacturing, packing and documentation. **Position Summary** This position is 100% on-site at the Greenville site. 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. The Development Scientist II is responsible for all formulation and process development of several ongoing projects including project management and customer contact. **The Role** * Responsible for GMP compliance in formulation and process development. * Responsible for assisting with planning and operating within a budget for the pharmaceutical area. * Work directly with customers and potential customers to agree on development approaches and scope of work. * Independently assist manufacturing group with batch manufacture and packaging/labeling, including set-up and cleaning. * Lead efforts in solving formulation and process problems. * Directly support with writing batch records, SOPs, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed. * Ensure that all work is accurate, precise, properly documented and, when appropriate, performed within GMP guidelines. * All other duties as assigned. **The Candidate** * Bachelor’s degree in Pharmacy, Chemistry, Biology or related field with eight or more years of experience in pharmaceutical development w
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