Study Director

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.