Boston Metro Area, MA
This position is within the Analytical Development group for protein therapeutics in early stage development (Phase I/II). The candidate will be responsible for:
1. Develop and qualify analytical methods involving spectrophotometry, gel and capillary electrophoresis, liquid chromatography (IEX, SEC and reversed-phase separations), and mass spectrometry for the purposes of drug substance and/or drug product lot release and stability testing
2. Participate in sample testing under cGMP environment and ensure the test is performed within the test window and the results are correctly entered into LIMS system in a timely manner.
3. Author assay development reports, assay qualification protocols, assay qualification reports, and SOPs.
4. Comply with departmental SOPs, safety guidelines, and other applicable regulations.
The successful candidate must be able to work effectively under minimal supervision, as well as handling multi-tasks spontaneously and meeting timelines efficiently and productively.
Experience: 0 to 3 years.
The preferred candidate should have a fundamental knowledge of cGMP, strong technical skills in protein separations such as HPLC, cIEF, and CE-SDS, and excellent compliance and organizational skills. A proficiency using Word and Excel for technical documentation is desired as well as the ability to write and communicate scientific data effectively.
B.S. in Chemistry, Protein Biochemistry or related discipline