AD/QC Analyst

Northway Biotech•Waltham, MA

About The Position

The AD/QC Analyst will be responsible for assay optimization, qualification, and validation, and technology transfer for proteins and other biomolecules. This role involves method development for identity, purity, aggregation status, charge isoforms, and potency using various chromatography and electrophoresis techniques, as well as other protein chemistry tools. The analyst will support process development, release testing, and stability studies. Additional duties include mass spectrometry analysis of proteins and fragments, peptide mapping, data management, cross-functional coordination, data interpretation, technical report contribution, issue identification and resolution, audit participation, and ensuring high-quality documentation.

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.
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.

Nice To Haves

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.

Responsibilities

Responsible for assay optimization, qualification, and validation, and technology transfer for proteins and other biomolecules.
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.