Analytical Sciences Specialist I — Method Transfer & GMP

Emergent BioSolutions; Canton (MA); On-site; USD 98,000 - 118,000; Full time

Benefits offered by this job

Annual bonus

Stock options

Equal Opportunity Employer

Job summary

Emergent BioSolutions is a leading public health company dedicated to protecting and saving lives. The Specialist I, AS&T supports analytical methods and laboratory systems across AST, QC, and Manufacturing Technology to ensure compliant, reliable operations.

The role oversees method transfer/validation, instrument qualification, and data integrity within a cGMP/GLP framework, enabling robust analytical performance and lifecycle support for vaccines and biotherapeutics.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or related field with at least 5 years of relevant experience.
• Experience with immunological, bioanalytical and chemical test methods such as ELISA, qPCR, IEF, viral and cell-based assays, SDS-PAGE, Western blot, DNA sequencing, microbiological methods, sterility testing, endotoxin testing, HPLC, CE, and UV/IR spectroscopy.
• Advanced knowledge of USP/EP, cGMPs, 21 CFR 11, and data integrity; experience with analytical methods, laboratory instrumentation, and regulated quality systems.

Responsibilities

• Support transfer of analytical methods, including authoring and executing method transfer, verification, and validation protocols and reports.
• Execute analytical studies, analyze and interpret data, investigate analytical issues, and contribute to effective resolutions.
• Support analytical instrument qualification activities and maintain laboratory systems in compliance with 21 CFR Part 11 and GMP/GLP.
• Author and support laboratory investigations, deviations, CAPAs, and change controls related to analytical methods and systems.

Skills

Analytical methods

Laboratory techniques

Statistical analysis

Quality systems

Education

Bachelor’s degree in Chemistry, Biochemistry, Biology

Tools

ELISA

qPCR

HPLC

SDS-PAGE

Western blot

DNA sequencing

LIMS

Job description

Emergent BioSolutions is a leading public health company dedicated to protecting and saving lives. The Specialist I, AS&T supports analytical methods and laboratory systems across AST, QC, and Manufacturing Technology to ensure compliant, reliable operations.

The role oversees method transfer/validation, instrument qualification, and data integrity within a cGMP/GLP framework, enabling robust analytical performance and lifecycle support for vaccines and biotherapeutics.