Study Director, Cell Services

Job Description
Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA and Belgium. Our mission continues to focus on providing quality pre-clinical services, competitively priced, with on-time delivery for the Pharmaceutical, Medical Device and Biotech industries.

Toxikon is seeking a Study Director for its Cell Services group. The Study Director has overall responsibility for the technical conduct of safety testing studies according to GLP regulations and represents the principal point of study control for activities related to compliance for in-vitro studies. Responsibilities include but are not limited to: protocol approval, supervision of the conduct of the study experiment according to protocol, documentation of protocol deviations and amendments, reviewing data, conducting and/or approving data analysis, ensuring accurate incorporation of results and conclusions into the study report prior to submission to the Sponsor, working closely with the Sponsor to address study changes, and ensuring archiving of study records. The Study Director is responsible for meeting study timelines and quality standards, and training/mentoring scientific laboratory research associates and/or other junior study directors to department or study specific SOPs.

The main focus for this position is to develop new assays in response to specific requests from our clients, as well to improve the tests we offer. Of particular interest are assays around T-cells, Immunology, in vitro ADME and Receptor binding. Experience with ELISA and PCR required. An interest in regulatory concepts is desired.

Responsibilities for this position will be allocated as follows:
65% in the lab performing experiments
20% data interpretation and report writing
15% scientific literature search

The successful candidate will have at least 5 years of experience in the lab; possess excellent written and oral communication skills, with the ability to be a team player. The ideal person will have extensive experience with a wide variety of assays, and the ability to create or follow an organized process for assay development.

Company

Toxikon Corporation

Job Code

State or Province

Massachusetts

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