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.