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Boston Metro Area, MA

Post Date: 06/30/2017 Job ID: JN -062017-19432
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.

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