Position responsibilities:
· Responsible for assay optimization, qualification, and validation, and technology transfer for proteins and other biomolecules.
· Additional responsibilities include but are not limited to method development for identity, purity, aggregation status, charge isoforms, and potency using chromatography (including SEC, RP-HPLC, IEX, HIC, affinity, etc.), electrophoresis (including SDS-PAGE, Western blotting, IEF, and cIEF), and other protein chemistry tools.
· Support upstream and downstream process development in-process testing, drug substance/drug product release testing, and stability study testing.
· MS analysis of intact proteins and fragments generated by various enzyme digestion; peptide mapping analysis by LC-MS for protein amino acid confirmation and relative qualification of post-translational modifications.
· Generate, manage, evaluate, and maintain data in a highly organized manner.
· Coordinate with cross-functional departments on various projects.
· Interpret data and contribute to technical reports.
· Identify technical issues and implement solutions.
· Participate in internal and external audits and inspections.
· Ensure high-quality, timely documentation in laboratory notebooks and technical reports.
Position requirements:
· Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field
· Minimum of 3 years of experience in analytical development and quality control within the pharmaceutical or biotechnology industry.
· Expertise in characterizing protein structure including molecular weight, aggregation state, glycan structure, etc.
· Experience in enzyme protein and mAb intact mass analysis, peptide mapping analysis, glycan analysis by LCMS is preferred.
· Deep understanding of mAb and protein molecular and biochemistry, post-translational modifications, glycosylation structures, and developability liabilities is a plus.
· Familiarity with protein/biomolecule assay development, optimization, qualification, and validation is required.
· Ability and desire to work in a fast-paced, start-up environment.
· Strong collaboration, team-working, documentation, and communication skills.
· Independently motivated and detail-oriented with good problem-solving ability.
· Must be able to work effectively in cross-functional teams.