| Description: The Organic Chemistry Group of Siemens Healthineers Laboratory Diagnostics, located in Walpole, Massachusetts, is responsible for the development and manufacturing of critical reagents used in in-vitro diagnostic products. The group has an immediate opening for a contract analytical/validation chemist.
The position will involve several projects. The first project is installation and performance validations (test method validations) of two Waters' 1525 analytical HPLCs used for analysis of FDA-regulated production materials destined for in-vitro diagnostic products. Validation activities include sample preparation and analysis of test materials of small organic molecules and peptides, data analysis, writing of process descriptions and data into formalized pre-set document templates such as technical studies and reports, along with validation protocols and reports. The second project is installation and operation qualification of a new LC/MS to be purchased. The candidate will generate installation and operation protocols, carry out validation experiments and write reports. The candidate will also write instrument operating procedures and train employees. Further, the candidate will develop and validate the LC/MS methods for exiting products that are currently analyzed by HPLC.
Familiarity with Waters’ 1525 HPLC, ACQUITY UPLC, SQD 2 Mass Detector and Empower 3 software or similar models and software is required. Proficiency in technical writing is also required, as is experience working with change control and validation of analytical equipment/methods in a GLP and GMP laboratory. Although not necessary for this position knowledge of organic synthetic routes and purification schemes would be advantageous. Similarly, experience with other analytical methods such as mass spectrometry, NMR, and UV-visible would also be useful. The work environment will involve collaboration with organic chemists within the group, and interaction with quality assurance and validation personnel in separate departments. At all times the candidate must be able to work safely and independently in a team environment, and manage several projects simultaneously and efficiently.
Education: Bachelor’s degree in chemistry with 5+ years’ experience, or Master’s/PhD degree in analytical chemistry with 0-2+ years, of relevant experience in HPLC and LC/MS analysis and validation. Industrial experience is preferred