Job Title: Research Associate/Scientist
FLSA Status: Exempt
Job Number: 10270608
Department: Analytical Development
Description:
As a Research Associate or Scientist (dependent upon experience), this position will assist the Stability Manager in operation of Arena's development stability programs.
Essential Duties and Responsibilities:
- Review and compile stability study protocols, data, and reports in accordance with current regulatory guidelines;
- Develop appropriate systems and procedures with regards to the performance and monitoring of drug substance and drug product stability;
- Coordinate the routine maintenance and calibration of equipment used in the performance of stability studies;
- Coordinate the activities of contract laboratories as they pertain to either drug substance or drug product stability;
- Write appropriate reports required for the CMC section of regulatory filings;
Job Requirements:
Education: B.S. or M.S. in Chemistry or related field
Experience: Entry-level up to 10 years in pharmaceutical industry along with analytical chemistry and chromatography expertise.
Specific Skills:Working knowledge of GLP/GMP regulations, excellent communication skills and the ability to work within a team setting is required.
Supervisory Responsibilities: None
Physical Demands/Work Environment: This position is in a relatively quiet office environment including sitting, keyboarding, filing, and talking on the phone/in person, as well as other office related activities such as attending meetings. Approximately 90% of time spent sitting at a desk, working on a computer/keyboard, and 10% walking.
