Boston Metro Area, MA
Biologic Drug Product Development (BDPD) is responsible for the late stage biopharmaceutical formulation/fill finish process development, process scale up, and technology transfers to manufacturing or CMO. This multi-disciplinary team interacts intensively with many functional groups, including early formulation, process development, analytical, regulatory, clinical, and commercial manufacturing, for the pipeline product development. BDPD has also provided technical support for commercial manufacturing, clinical trial material production, manufacturing deviation investigation, process tech transfer/validation, and regulatory response.
We are looking for a Laboratory Analyst I to join our department. The incumbent will be responsible for preparing buffer and formulation solutions, conducting protein sample analysis using different analytical techniques, including HPLC, Microflow imaging, HIAC, spectrophotometry, oxygen headspace, etc. The analyst will be responsible for executing IV studies and IV syringe pump studies according to protocols. Experimentation may include frozen bulk development with preparation that includes cleaning and sterilization of vials and stoppers. Additional tasks may include biologics fill finish process development (e.g. materials identification with Raman spectroscopy, filter integrity testing, and peristaltic pump development). Other responsibilities will include filling of vials for lyophilization and maintaining an electronic lab notebook of studies conducted.
The candidate has to be self-motivated, with 0 to 3 years of experience, with an understanding of protein biochemistry.