Specialist I, AS&T

About the role

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Responsibilities

• Support analytical methods and laboratory systems in a compliant state throughout their lifecycle.
• Support analytical method transfer, verification, and validation activities.
• Contribute to analytical instrument qualification and implementation for GMP use.
• Provide technical support across Analytical Sciences & Technology (AST), Quality Control, and Manufacturing Technology functions to ensure compliant, reliable analytical operations.
• 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.
• 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.
• 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.
• 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.

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.

Pay

The estimated annual base salary as a new hire for this position ranges from $97,500 to $117,900. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.