Summary

Northway Biotech is a leading Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical services with global operations spanning the United States, Lithuania, and the United Kingdom. Founded in 2004, the company has established itself as a premier provider of end-to-end biologics development and manufacturing solutions, serving clients worldwide with expertise spanning from early-stage research to commercial-scale production. Northway Biotech's comprehensive service portfolio includes mammalian and microbial cell line development, upstream and downstream process development, analytical methods development, formulation development, and cGMP manufacturing of biologics, biosimilars, and gene therapy products. The company operates state-of-the-art GMP facilities in Waltham, Massachusetts (USA) and Vilnius, Lithuania, with additional presence in London, UK. Northway Biotech has successfully executed over 205 projects for global biopharmaceutical clients, demonstrating its capability to support complex biologics programs. The company's vertically integrated approach enables seamless transition from development to manufacturing, with specialized capabilities in pDNA manufacturing, monoclonal antibody production, and fill/finish operations. Recognized with the 2025 CDMO Leadership Awards in the Global Biologics category, Northway Biotech combines scientific excellence with operational flexibility to accelerate the development of innovative therapies for patients worldwide.

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.

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

Company overview

Northway Biotech is a leading Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical services with global operations spanning the United States, Lithuania, and the United Kingdom. Founded in 2004, the company has established itself as a premier provider of end-to-end biologics development and manufacturing solutions, serving clients worldwide with expertise spanning from early-stage research to commercial-scale production. Northway Biotech's comprehensive service portfolio includes mammalian and microbial cell line development, upstream and downstream process development, analytical methods development, formulation development, and cGMP manufacturing of biologics, biosimilars, and gene therapy products. The company operates state-of-the-art GMP facilities in Waltham, Massachusetts (USA) and Vilnius, Lithuania, with additional presence in London, UK. Northway Biotech has successfully executed over 205 projects for global biopharmaceutical clients, demonstrating its capability to support complex biologics programs. The company's vertically integrated approach enables seamless transition from development to manufacturing, with specialized capabilities in pDNA manufacturing, monoclonal antibody production, and fill/finish operations. Recognized with the 2025 CDMO Leadership Awards in the Global Biologics category, Northway Biotech combines scientific excellence with operational flexibility to accelerate the development of innovative therapies for patients worldwide.