• Act as the key expert in the characterization of monoclonal antibody (mAb), antibody drug conjugate (ADC) including PTMs, such as glycosylation using LC-MS, peptide mapping, or other techniques. Provide scientific input into study design and execution.
• Carry out tests including, not limited to peptide mapping and intact mass LC-MS, glycan, HPLC (RP, IEC, and HIC), CE-SDS, cIEF, etc.
• Compile analytical data, perform data analysis and interpretation, prepare technical report, present data to project teams, give oral presentation at internal or external meetings.
• Develop, qualify, and transfer physiochemical assays, prepare SOPs and assay development reports, and provide expertise guidance to troubleshooting.
• Identify and define critical quality attributes (CQA) in early analytical development stage.
• Effectively work with colleagues in upstream and downstream process development group.
• Responsible for maintaining and ensuring adherence to GMP compliance.
• Support regulatory filing and review technical documents.
• Order and maintain laboratory reagents and supplies as needed, perform tasks as assigned.
• MS or Ph.D. in Biochemistry, Biophysics, Chemical Engineering, Biology, other relevant scientific field. MS with 3-8 years or Ph.D. with 0-5 years biopharmaceutic industry or academic experience with focus on characterization or method development for proteins or glycans.
• Extensive hands-on experience in peptide mapping, intact mass LC-MS, disulfide bond mapping, glycan is required. Experience in method development with HPLC (SEC, RP, IEC, HIC, Protein A,) and electrophoresis (CE-SDS and cIEF) is preferred.
• Experience in post-translational modification characterization of proteins, glycan analysis, IND filing, report authoring, SOP authoring, assay development.
• Able to introduce new technologies to improve the performance and efficiency of assays.
• Strong technical competency in analytical development and troubleshooting for instrument failure, assay failure, or any testing failure.
• Good understanding of cGMP regulation relevant to biotherapeutic drug product development.
45 West Watkins Mill Road, Gaithersburg, MD
• Strong verbal and written communication skills and ability to manage multiple tasks
simultaneously and pay attention to details.
• Ability to work independently in a small company setting with limited operational support.