Study Director - Biocompatibility Studies

Supervise and assist in the conduct of regulatory studies performed.  Responsibilities include: • Supervise study conduct. • Assist in protocol development, design and implementation. • Responsibilities as stated in GLP regulations. • Data interpretation and report writing. • Client liaison. Management Responsibilities: • Overall, day-to-day laboratory operation including supervision of technical staff assigned to your studies. • Scheduling and coordinating initiation and conduct of studies. • Ensure that the study schedule and financial aspects of each study that you are responsible for are accurately tracked on a regular basis. Technical Responsibilities: Overall responsibility for the technical conduct of all studies and interpretation, analysis, documentation and reporting of results.  Specifically: • Establish test protocols and corresponding SOP's. • Develop experimental design and supervise implementation of experiments (tests). • Obtain sponsor approval of protocols and institute any necessary deviations from the test protocol with sponsor approval. • Ensure all experimental data is properly recorded and that observations of unanticipated responses of the test system are accurately recorded and verified. • Ensure tests are conducted in accordance with the test protocol and SOP. • Supervise conduct of all phases of the study, including participation in study conduct. • Ensure that GLP regulations are followed. • Interpretation, calculation, analysis, documentation and reporting of results. • Instruct, train and supervise scientists in all procedures. • Maintain liaison with sponsors, advising them of test results; and assisting with protocol development. • Maintain liaison with regulatory agencies in conjunction with: test protocols, and past or present studies submitted for regulatory approval, compliance with GLP's and appropriate test guidelines. • Ability to safely wear a respirator required • BS degree in a field related to their area of responsibility (e.g. animal science, chemistry, biology, microbiology). • Minimum of 5 years experience overseeing biocompatibility studies • Intimate working familiarity and/or ability to quickly learn and develop such familiarity with all government regulations dealing with testing particularly EPA, FDA, DOT, OECD, and GLP regulations in addition to ISO standards. • Hands-on working knowledge of the tests that will be under their responsibility. • Good administrative skills and leadership ability. Must communicate effectively and write well. Position is full-time, Monday-Friday, 9:00am.- 5:00 pm, with overtime as needed.  Candidates currently living within a commutable distance of Dayton, NJ are encouraged to apply. Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.