We are currently recruiting for a Pharmaceutical Development Scientist I to join our team in the Cary, NC location. The Pharmaceutical Development Scientist I is responsible for managing the pharmaceutical development activities for various drug, biologic or medical device products. Responsibilities may include drug substance synthesis, preformulation, formulation, manufacture, scale-up, process validation, analytical methods development and validation, packaging and labeling. The Pharmaceutical Developmnet Scientist I conducts GMP and GLP audits of contractors including analytical laboratories, manufacturing, and packaging and labeling facilities, participates in FDA teleconferences and meetings, and prepares CMC-related regulatory submissions, including INDs, NDAs, 505b2s, and BLAs.
Responsibilities:
- Write regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought
- Guide the writing of regulatory/scientific documents written by other project team members
- Serve as scientific reviewer of regulatory/scientific documents in specific areas of technical expertise
- Contribute significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects
- Assist in the evaluation of potential technologies and preparation of business development proposals with primary emphasis on scientific aspects
- Assist in the development and management of projects
- Receives general instructions on routine work and detailed instructions on new assignments
- Applies company policies and procedures to resolve a variety of issues
Qualifications:
- Requires a R.Ph. M.S., Ph.D., or equivalent degree, in a scientific area, or B.S., degree in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
Skills:
- Critical thinking and analytical skills, as well as strong written and verbal skills in English
- Scientific and regulatory knowledge of drug, biologic, or device development, desirable
- Minimum of 2 years' post-degree of directly relevant experience in drug, biologic, or device development, desirable
