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.