AD/QC Analyst Quality Control · Northway Biotech (Biologics)- Waltham · Onsite

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.