Specialist I, AS&T
Emergent BioSolutions
August 11, 2026
Remote friendly (Canton, MA)
United States
IT
Job Summary
The Specialist I, AS&T (Analytical Sciences & Technology) supports analytical methods and laboratory systems in a compliant state throughout their lifecycle. Supports analytical method transfer, verification, and validation and contributes to analytical instrument qualification and implementation for GMP use across AST, Quality Control, and Manufacturing Technology.
Responsibilities
- Support analytical method transfer, including authoring/executing transfer, verification, and validation protocols and reports.
- Execute analytical studies; analyze/interprete data; investigate analytical issues; support resolutions.
- Assess method performance and suitability for intended GMP use.
- Perform technical writing (SOPs, protocols, reports).
- Support analytical instrument qualification (author URS, qualification protocols/reports; execute qualification activities).
- Support laboratory systems compliance with cGMP/GLP and 21 CFR Part 11; maintain data integrity and contemporaneous documentation.
- Support LIMS activities, including UAT and execution of test scripts (as applicable).
- Author/support investigations, deviations, CAPAs, and change controls related to analytical methods and systems.
- Contribute to continuous improvement in AST laboratory operations.
- Provide cross-functional technical support to QC, Manufacturing Technology, and other teams.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Biology, or related field; 5+ years relevant experience.
- Knowledge of immunological, bioanalytical, and chemical test methods (e.g., ELISA, qPCR, IEF, cell/viral assays, SDS-PAGE, Western blot, DNA sequencing, microbiology, sterility/endotoxin testing, HPLC, CE, UV/IR spectroscopy).
- Advanced knowledge of USP/EP, cGMPs, 21 CFR Part 11, and data integrity; understanding of analytical methods, instrumentation, and quality systems.
- Experience with method qualifications/validations; assay and equipment validation; analytical investigations for biotherapeutic/vaccine products.
- Ability to apply statistical analysis to QC monitoring and trending.
Compensation/Benefits
- Estimated base salary (new hire): $97,500–$117,900; additional incentives may apply.
- Comprehensive benefits package (eligibility governed by plan documents).
Application Instructions
- If selected for interview, speak with an HR Partner about compensation philosophy and available benefits.
The Specialist I, AS&T (Analytical Sciences & Technology) supports analytical methods and laboratory systems in a compliant state throughout their lifecycle. Supports analytical method transfer, verification, and validation and contributes to analytical instrument qualification and implementation for GMP use across AST, Quality Control, and Manufacturing Technology.
Responsibilities
- Support analytical method transfer, including authoring/executing transfer, verification, and validation protocols and reports.
- Execute analytical studies; analyze/interprete data; investigate analytical issues; support resolutions.
- Assess method performance and suitability for intended GMP use.
- Perform technical writing (SOPs, protocols, reports).
- Support analytical instrument qualification (author URS, qualification protocols/reports; execute qualification activities).
- Support laboratory systems compliance with cGMP/GLP and 21 CFR Part 11; maintain data integrity and contemporaneous documentation.
- Support LIMS activities, including UAT and execution of test scripts (as applicable).
- Author/support investigations, deviations, CAPAs, and change controls related to analytical methods and systems.
- Contribute to continuous improvement in AST laboratory operations.
- Provide cross-functional technical support to QC, Manufacturing Technology, and other teams.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Biology, or related field; 5+ years relevant experience.
- Knowledge of immunological, bioanalytical, and chemical test methods (e.g., ELISA, qPCR, IEF, cell/viral assays, SDS-PAGE, Western blot, DNA sequencing, microbiology, sterility/endotoxin testing, HPLC, CE, UV/IR spectroscopy).
- Advanced knowledge of USP/EP, cGMPs, 21 CFR Part 11, and data integrity; understanding of analytical methods, instrumentation, and quality systems.
- Experience with method qualifications/validations; assay and equipment validation; analytical investigations for biotherapeutic/vaccine products.
- Ability to apply statistical analysis to QC monitoring and trending.
Compensation/Benefits
- Estimated base salary (new hire): $97,500–$117,900; additional incentives may apply.
- Comprehensive benefits package (eligibility governed by plan documents).
Application Instructions
- If selected for interview, speak with an HR Partner about compensation philosophy and available benefits.