The Bioanalytical Scientist will serve as a technical resource in bioassay implementation, validation, execution, and monitoring in a cGMP laboratory.
MAJOR RESPONSIBILITIES:
Implementation, validation, troubleshooting, and monitoring of bioassays in a cGMP laboratory. Collaborate cross-functionally with Research, Analytical Development, QC, and QA, to identify areas where assays are required and to implement assays in a cGMP environment. Establish bioassay method monitoring.
QUALIFICATIONS:
Ph.D. in Bioanalytical Chemistry, Analytical Biochemistry or related discipline, with a minimum of 5 years relevant hands-on experience beyond degree. Will consider a B.S. or M.S. in the fields listed above with a minimum of 8 years of relevant hands-on experience. Prior experience with a variety of complex analytical, physical, and bioanalytical (bioassay, immunoassay, cell-based assay) measurement techniques. Experience with assay qualification, validation, and transfer in a cGMP environment Demonstrated strong experimental design and problem solving skills. Strong statistical and data analysis skills required. Firm understanding of GMPs, GLPs, 21 CFR Part 11 and FDA/EMEA Bioanalytical Guidance required. Demonstrated collaborative capacity.
Job Location Cambridge, MA, US. Position Type Full-Time/Regular