Associate Director/Director of R&D

If you are beginning to think of quality of life issues but still want to maintain and/or continue to grow in your career in management of R&D we might have a position for you. If you want to live where there is economic prosperity, the presence of Fortune 500 companies and a variety of educational, recreational, cultural opportunities with out the high cost of living maybe this is for you.  Our client is the 7th largest generic pharmaceutical company in the US with many years of a stable environment that has over 500 product lines and 640 employees is now seeking an Associate Director/Director of R&D.

 

This position is responsible for directing the development and validation of the analytical methodology for drug substances, in-process materials, and drug products. This position works closely with Pharmaceutics and Pharmaceutical Technology Departments in developing new products and product transfers. Specific areas of accountability include the following: -Provides general analytical support to the manufacturing sites. -Writes and reviews analytical documents including SOPs, INDs, NDAs, test methods, calibration procedures, etc. -Provides responses to FDA questions and interact with FDA reviewers as needed. -Evaluates new technologies in relation to company projects and priorities. Evaluates and recommends purchases for analytical instrumentation. -Supervises analytical bench chemists. This involves supervising productivity, maintaining data standards and quality, conducting performance appraisals, handling personnel issues, and setting priorities. -Manages data collection, analysis. and interpretation. Draws conclusions from the data and makes recommendations. This position requires a candidate with an established supervisory background and a thorough knowledge of IND, NDA submission, FDA and ICH guidance.