Toxikon Corporation, originally founded in 1977, is a Contract Research and testing company with laboratories in Bedford, MA. 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 In Vitro/Cell Based Assay 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.
Job Duties and Responsibilities
· 60% reviewing protocols and data generated by the lab and reporting data
· 20% interaction with clients, sales and other administrative functions
· 20% lab work
The main focus for this position is on in vitro studies, hemocompatibility, ELISA, cell culture cytotoxicity assays, and other studies for pharmaceutical products and medical devices. Ph.D. or M.S. with at least 4-6 years of experience required in-vitro laboratory work, including mammalian cell culture required: Prior background and experience in a hematology laboratory required. Experience with ISO, USP, ASTM and other guidelines a plus.
- Strong scientific analytical skills in data analysis, reviewing GLP data and writing regulated study reports.
- Strong organizational skills and work ethic. Maintain accurate schedule and follow-up efficiently.
- Communicate clearly and cautiously, both written and oral.
- Attain a strong knowledge of GLP regulation and work closely with regulatory affairs on interpretation issues.
This position is located in Bedford, MA.
For additional information about Toxikon go to www.toxikon.com.
Toxikon offers a comprehensive benefits program including: paid vacation sick time, 401(k) plan with company match, medical, dental, vision, life insurance, short and long-term disability insurances, flexible spending accounts, employee assistance program, employee referral bonus, discount programs and more.
Toxikon is an equal opportunity employer. As an equal opportunity employer we do not unlawfully discriminate against any applicant because of race, sex, gender, ethnicity, religion, creed, age, color, military/veteran status, genetic condition or information, Family and Medical Leave entitlement, sexual orientation, gender identity, national origin, ancestry, marital status, qualified physical or mental disability, transgender status, or any other legally protected class in accordance with federal, state, and local laws.
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