The Scientist, Biologics (Biophysical Characterization) will act as a subject matter expert in higher-order-structure (HOS) and biophysical characterization of protein and peptides and operate in the lab as an independent researcher. Knowledge and experience in the analysis of primary, secondary, tertiary protein/peptide structure using amino acid analysis (AAA), N-terminal sequencing, circular dichroism (CD), FTIR, and/or DSC and analysis of protein quaternary structure and aggregates using SEC-MALS, svAUC, and/or DLS is highly desired. In this position, you will conceive, implement, analyze experiments to produce fully independent data. Furthermore, you will be responsible for participating in method development, validation, and transfer of methods used in the testing of biopharmaceutical products or raw materials. This position will require interaction with clients and involve presenting data in meetings in clear and concise manner. In addition, this position will involve managing lower-level analysts in their daily activities to ensure completion of small- to mid-size projects in a timely manner to the satisfaction of both SGS and the client.Perform evaluation of sophisticated analytical equipment or software, providing expert opinion on quality and feasibility with respect to their use in the LaboratoryPerform the development and validation of analytical testing procedures for drug substances and drug productsWrite protocols, drafts methods, and technical reportsKeep all records and lab notebooks in good order. Analyze testing data, enter the testing results into the company’s electronic system for a certificate of analysis and prepare reports, if required, in a timely mannerGuide Analysts in their workCoordinate method transfers between clients and SGSParticipate in investigations for OOS, OOT, and deviations. Participate and execute CAPAExecutes experiments, following the company’s SOPs, Deviations, and Change Control programs and cGMP guidelinesEnsure that equipment is maintained properly; perform calibrations and qualifications as requiredProvide expert technical support to clients, internal and other SGS groupsRepresent Company and Company policies as needed during client visits and regulatory agency inspectionsEnsure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective mannerParticipate in departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratoryPerform other assigned lab duties as requested.
