Specialist I, AS&T

Emergent Biosolutions•Canton, MA

3d•$97,500 - $117,900

About The Position

The Specialist I, AS&T (Analytical Sciences & Technology) is responsible for supporting analytical methods and laboratory systems in a compliant state throughout their lifecycle. The role supports analytical method transfer, verification, and validation activities and contributes to analytical instrument qualification and implementation for GMP use. The Specialist I provides technical support across AST, Quality Control, and Manufacturing Technology functions to ensure compliant, reliable analytical operations.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific discipline with at least 5 years of relevant experience.
Must possess skills and knowledge of general 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 with multiple modes of detection, CE, and UV and IR spectroscopy.
Advanced knowledge of USP/EP, cGMPs, 21CFR part 11, and data integrity with foundational understanding of analytical methods, laboratory instrumentation, and regulated quality systems desirable
Experience in executing phase appropriate method qualifications and validations.
Experience in assay method validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products.
Ability to apply statistical analysis to QC monitoring and trending

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 assessment of method performance and suitability for intended GMP use.
Support analytical instrument qualification activities, including authoring User Requirement Specifications (URS), qualification protocols/reports, and executing qualification activities.
Support implementation and maintenance of laboratory systems in compliance with cGMP/GLP and 21 CFR Part 11 requirements.
Support site level LIMS activities, including User Acceptance Testing (UAT) and execution of test scripts, as applicable.
Author and support laboratory investigations, deviations, CAPAs, and change controls related to analytical methods and systems.
Support maintenance of data integrity and contemporaneous documentation in accordance with GMP expectations.
Contribute to continuous improvement initiatives within AST laboratory operations.
Interact with Quality Control, Manufacturing Technology, and other functional groups on technical topics and cross functional projects related to analytical sciences.
Provide technical support as assigned to ensure timely and compliant project execution.