Development Scientist II
About The Position
The Development Scientist II serves as a primary client contact for pharmaceutical development and clinical manufacturing project activities. The role supports supervision, process development, clinical trial batch manufacturing, packaging, and documentation. This position is 100% on-site at Catalent’s Greenville, North Carolina facility, which provides end-to-end solutions for oral solid dosage forms, including formulation development, analytical services, commercial manufacturing, and packaging. The scientist is responsible for formulation and process development across several ongoing projects, including project management and customer contact. The role also supports GMP compliance, budget planning and operation, clinical batch manufacture, packaging and labeling, and preparation of development and regulatory documentation.
Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field, with at least 8 years of pharmaceutical development experience focused on solid dosage formulation; or
- Master’s degree in Pharmacy, Pharmaceutics, Industry Pharmacy, or a related field, with at least 6 years of pharmaceutical development experience; or
- Ph.D. in Pharmacy, Pharmaceutics, Industry Pharmacy, or a related field, with at least 4 years of pharmaceutical development experience.
- Some exposure to hazardous chemicals and other active chemical ingredients.
- Ability to handle and manipulate objects using hands and arms.
- Ability to occasionally lift items weighing more than 50 pounds.
- Ability to wear a respirator and complete a medical evaluation with satisfactory results.
Responsibilities
- Serve as a primary point of contact for customers regarding pharmaceutical development and clinical manufacturing project activities.
- Manage formulation and process development for several ongoing projects, including project management and customer contact.
- Ensure GMP compliance in formulation and process development.
- Assist with planning and operating within a budget for the pharmaceutical area.
- Work with current and potential customers to agree on development approaches and scope of work.
- Assist the manufacturing group independently with batch manufacture and packaging or labeling, including setup and cleaning.
- Lead efforts to solve formulation and process problems.
- Support preparation of batch records, SOPs, IQ/OQ/PQ documents, development and technical reports, and CMC sections for regulatory submissions as directed.
- Ensure work is accurate, precise, properly documented, and, when appropriate, conducted within GMP guidelines.
- Perform other duties as assigned.
Benefits
- 152 hours of PTO
- 8 paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
