Study Director

RXinsider LTD.; South Brunswick, Northern (NJ, KY); Hybrid; USD 95,000 - 135,000; Full time

Job summary

Eurofins USA BioPharma Services in Dayton, NJ seeks an experienced supervisor to oversee regulatory studies, ensure GLP compliance, and interpret data. You will develop protocols, train staff, and liaise with sponsors.

This role requires a BS degree, at least five years of biocompatibility study oversight, and strong knowledge of EPA, FDA, DOT, OECD, GLP, and ISO standards. Full-time with weekday hours and potential overtime.

Qualifications

• BS degree in a field related to their area of responsibility.
• Minimum of 5 years experience overseeing biocompatibility studies.
• Familiarity with EPA, FDA, DOT, OECD, GLP regulations and ISO standards.
• Hands-on working knowledge of the tests under their responsibility.
• Strong administrative and leadership skills; effective communication and writing.

Responsibilities

• Supervise study conduct.
• Oversee day-to-day laboratory operations and staff.
• Coordinate initiation and conduct of studies and track schedules and finances.
• Ensure GLP compliance and accurate data reporting.

Skills

Good administrative skills

Education

BS degree

Job description

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labeling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

Job Description

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

Qualifications

• 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.