Specialist I, AS&T

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

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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.

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 management’s 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.

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.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non‑solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Emergent prepares those entrusted with protecting their communities against current and future health threats.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.