AD/QC Analyst

Northway Biotech, Inc.; Waltham (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Northway Biotech, Inc. is seeking a skilled analytical development professional to optimize and validate assays for proteins and biomolecules. You will develop methods to assess identity, purity, aggregation, and glycan structures using chromatography and electrophoresis techniques.

You will support process development, MS analyses, data management, and collaboration across teams, contributing to reports and audits while maintaining rigorous documentation.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 3 years in analytical development and quality control in pharma/biotech.
• Expertise in protein structure characterization including molecular weight and aggregation.
• Experience with enzyme and mAb intact mass analysis and peptide mapping by LC-MS.
• Knowledge of post-translational modifications, glycosylation, and developability liabilities.
• Familiarity with protein/biomolecule assay development, optimization, qualification, and validation.
• Ability to work effectively in a fast-paced start-up environment and cross-functional teams.

Responsibilities

• Optimize, qualify, and validate assays and support tech transfer for proteins and biomolecules.
• Develop methods for identity, purity, aggregation status, and glycan forms using chromatography and electrophoresis.
• Support upstream/downstream process development, in-process testing, and stability studies.
• Perform MS analysis on intact proteins and fragments; peptide mapping by LC-MS for confirmations.
• Generate, manage, and maintain data in an organized manner; interpret results.
• Coordinate with cross-functional teams; contribute to technical reports.
• Identify issues and implement solutions; participate in audits and inspections.
• Maintain high-quality documentation in lab notebooks and reports.

Skills

Analytical development

Quality control

Cross-functional collaboration

Data management

Documentation

Problem solving

Teamwork

Start-up environment

Education

Bachelor’s or Master’s in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

SEC

RP-HPLC

IEX

HIC

Affinity chromatography

SDS-PAGE

Western blot

IEF

cIEF

LC-MS

Peptide mapping

Glycan analysis

Job description

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.