AD/QC Analyst Quality Control · Northway Biotech; Biologics- Waltham
Job in
Northern, Floyd County, Kentucky, USA
Listed on 2026-10-12
Listing for:
Northway Biotech, Inc.
Full Time
position Listed on 2026-10-12
Job specializations:
-
Research/Development
Research Scientist, Biotech Research, Pharmaceutical Science/ Research
Job Description & How to Apply Below
- 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.
- 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 develop ability 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.
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