Job Summary

The Scientist-I position is an entry level, and it contributes to tasks associated to pharmaceutical analysis intended for drug product development. The preliminary activities include following schedules, direction of compendia standards and in-house standard operating procedures to analyze pharmaceutical drug substance, excipients, drug product testing for release and stability samples.

Essential Functions

• Perform quantitative analysis for pharmaceutical drug-substances, excipients and drug products using USP/NF, EP, in-house test methods and standard protocols, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs.
• Utilize techniques of Spectrophotometry, HPLC, GC, dissolution, and wet chemistry tests in accordance with the USP.
• Interpret and communicate analytical results.
• Contribute to technical problem solving and troubleshooting as needed.
• Contribute towards optimizing laboratory operations to increase efficiency and GMP compliance.

Education

• Bachelors Degree (BA/BS) in Chemistry or related science - Required

Work Experience

• 1 year or more pharmaceutical experience - Preferred

Skills and Abilities

• Microsoft Office and ability to learn additional software/programs as needed. - Intermediate
• Set priorities and follow through on commitments. - Beginner
• Meet deadlines under pressure. - Beginner
• Verbal and written communication skills. - Beginner
• Able to work in a team environment. - Beginner
• Creativity to solve technical and compliance problems. - Beginner
• Enthusiasm and dedication to learn analytical techniques. - Beginner

Specialized Knowledge

• Knowledge of US FDA- cGMP and Standard Operating Procedures (SOP).
• Understanding of analytical chemistry and analytical laboratory procedures.
• Background of modern analytical laboratory techniques and use of HPLC, GC, TLC, UV, and analytical equipment.
• Some knowledge of analytical Method development.