Study Director

Supervise and assist in the conduct of regulatory studies performed at Eurofins | Product Safety Labs (EPSL).  Responsibilities include:

1. Supervise study conduct.
2. Assist in protocol development, design and implementation.
3. Responsibilities as stated in GLP regulations.
4. Data interpretation and report writing.
5. Client liaison.

At least a Bachelor of Science degree or equivalent experience in a field related to their area of responsibility (e.g., toxicology, animal science, chemistry, biology, microbiology).

Intimate working familiarity and/or ability to quickly learn and develop such familiarity with all government regulations dealing with testing particularly EPA, FDA, DOT, FHSA, OECD, and GLP regulations.

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.

1.   Management Responsibilities:

1. Overall, day-to-day laboratory operation including supervision of technical staff assigned to your studies.
2. Scheduling and coordinating initiation and conduct of studies.

2.   Technical Responsibilities:  Overall responsibility for the technical conduct of all studies and interpretation, analysis, documentation and reporting of results.  Specifically:

1. Establish test protocols and corresponding SOP's.
2. Develop experimental design and supervise implementation of experiments (tests).
3. Obtain sponsor approval of protocols and institute any necessary deviations from the test protocol with sponsor approval.
4. Ensure all experimental data is properly recorded and that observations of unanticipated responses of the test system are accurately recorded and verified.
5. Ensure tests are conducted in accordance with the test protocol and SOP.
6. Supervise conduct of all phases of the study, including participation in study conduct.
7. Ensure that GLP regulations are followed.
8. Interpretation, calculation, analysis, documentation and reporting of results.
9. Instruct, train and supervise technicians in all procedures.

1. Maintain liaison with sponsors, advising them of test results; and assisting with protocol development.
2. 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.

• Any other duties assigned.

ACCOUNTABILITY:  Senior Study Director or Director level supervisor.