Study Director - Biocompatibility Studies
About The Position
The Study Director supervises and assists with regulatory biocompatibility studies, overseeing their technical conduct and ensuring compliance with study protocols, SOPs, GLP regulations, and applicable test guidelines. The role includes protocol development and implementation, experimental design, data interpretation and analysis, documentation, and report writing. The Study Director also serves as a liaison to sponsors and regulatory agencies and advises sponsors on test results and protocols. The position has day-to-day responsibility for laboratory operations and the technical staff assigned to studies. It includes scheduling and coordinating study initiation and conduct, tracking study schedules and financial aspects, and instructing, training, and supervising scientists. The role requires the ability to safely wear a respirator. This is a full-time position, Monday through Friday, 9:00 a.m. to 5:00 p.m., with overtime as needed. Candidates within commuting distance of Dayton, New Jersey, are encouraged to apply.
Requirements
- Bachelor of Science degree in a field related to the area of responsibility, such as animal science, chemistry, biology, or microbiology.
- At least 5 years of experience overseeing biocompatibility studies.
- Intimate working familiarity with, or ability to quickly learn and develop familiarity with, government testing regulations, particularly EPA, FDA, DOT, OECD, and GLP regulations, as well as ISO standards.
- Hands-on working knowledge of the tests under the role's responsibility.
- Good administrative skills and leadership ability.
- Effective communication skills and strong writing ability.
- Ability to safely wear a respirator.
Responsibilities
- Supervise study conduct and assist with regulatory studies.
- Assist with protocol development, design, and implementation.
- Manage day-to-day laboratory operations and supervise technical staff assigned to studies.
- Schedule and coordinate study initiation and conduct.
- Regularly track study schedules and financial aspects for assigned studies.
- Establish test protocols and corresponding SOPs.
- Develop experimental designs and supervise implementation of experiments and tests.
- Obtain sponsor approval of protocols and secure sponsor approval for necessary deviations.
- Ensure experimental data and observations, including unanticipated test-system responses, are properly recorded and verified.
- Ensure tests follow the test protocol and SOPs, and that GLP regulations are followed.
- Oversee all phases of studies, including participating in study conduct.
- Interpret, calculate, analyze, document, and report study results.
- Instruct, train, and supervise scientists in applicable procedures.
- Maintain sponsor liaison, advise sponsors of test results, and assist with protocol development.
- Liaise with regulatory agencies regarding test protocols, studies submitted for regulatory approval, GLP compliance, and applicable test guidelines.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
