AD/QC Analyst

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.