JOB SUMMARY 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. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Analytical Methods & Lifecycle Support • 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. • Technical Writing including SOPs, Protocols, Reports Instrument Qualification & Laboratory Systems • 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. Quality Systems & Compliance • 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. Cross Functional Support • 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. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS • Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. • 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 U.S. Base Pay Ranges and Benefits Information 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.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.