Boston Metro Area, Massachusetts
Employ in-depth technical knowledge in the field of analytical experiment design and execution often working independently to design and implement a series of experiments. A successful candidate must have strong organization skills and ability to write technical reports describing the experiments and their outcome. Experience in separation of biomolecules is a plus. Must be well-versed in the software and hardware for Seevers TOC, Waters HPLC and other laboratory instrumentation. Experience with TOC and cleaning validation is highly desired. Experience of working in a GMP regulated environment is a must. Experience with data bases is a plus. Experience: 3 to 6 years.
Instrument qualification including TOC, HPLC, plate readers and other laboratory equipment for a GMP laboratory operation.
Development and validation of analytical methodologies especially TOC methods related to cleaning validation/verification of manufacturing equipment in the manufacturing process.
Conduct TOC and other analytical testing in the QC laboratory under GMP conditions..
Support analytical activities related to computer system remediation s in the QC laboratories.
Mentor laboratory personnel in methods related to cleaning validation/verification.
BS in Analytical/Physical/Organic/Inorganic Chemistry.
3-5 years hands on experience in instrument qualification, method development/ validation and testing experience in a cGMP environment in a pharmaceutical or Medical Device required.