Pharmaceutical Development Scientist I

CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. CATO SMS is a non-laboratory environment.

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.

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.

• 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