Job Purpose:
As a member of the Regulatory Sciences team, act as Research Associate for PCR molecular analyses for regulatory biosafety studies. Responsible for following experimental and laboratory procedures according to agreed upon protocols, for collecting, organizing and summarizing study data and for providing support to other laboratory personnel.
Duties/Responsibilities
1. Provide molecular analysis support for Regulatory Sciences and Registration
a. Provide technical support to investigate, develop and/or adapt methods, as needed, to address:
i. Molecular technology issues within the laboratory
ii. New data requirements
iii. Country specific regulatory questions or requirements
b. Document experimental protocol, methods and results and prepare data in accordance with government regulatory requirements.
c. Maintain record management practices in accordance with Good Laboratory Practices and Client corporate records management guidelines.
d. Participate in experiments in compliance with Good Laboratory Practice requirements to answer key scientific questions.
e. Evaluate technical issues with regard to PCR technologies, research, work with other laboratory personnel to formulate experimental plan, communicate and perform implementation of next steps to address and resolve issue(s) in collaboration with laboratory personnel.
f. Maintain laboratory resources, e.g., inventory, safety, calibrations, etc.
2. Responsible for adherence to Good Laboratory Practices within the laboratory.
a. Follow Standard Operating Procedures (SOPs), methods and worksheets for analytical procedures and equipment such as sample weighing, DNA extraction, reagent preparation, genomic controls and PCR.
b. Responsible for equipment maintenance logs (daily, routine and non-routine) for the laboratory.
3. Support Regulatory studies related to regulatory trait package preparation.
a. Coordinate required research, greenhouse and laboratory efforts to obtain necessary materials (i.e. tissues, reagents, labware) for generation of required data.
b. Document and prepare study records.
