Analyst III, Method Transfer Sciences (Biochemistry)

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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 Analyst III, Method Transfer Services (Biochemistry) serves as a senior technical resource responsible for leading the transfer, validation, verification, troubleshooting, and lifecycle management of analytical and biological test methods within a regulated laboratory environment.

This role provides scientific leadership for complex method transfer projects involving analytical chemistry, bioassays, immunological methods, and other advanced analytical technologies.

The Analyst III collaborates cross-functionally with internal and external stakeholders to ensure transferred methods are scientifically sound, fit for purpose, and compliant with regulatory and GMP requirements.

The position also provides mentoring and technical guidance to junior staff while supporting laboratory planning, scheduling, and continuous improvement activities.

Responsibilities
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Technical Leadership

• Lead and independently execute analytical and biological method transfers, validations, verifications, and lifecycle management activities.
• Serve as a subject matter expert for analytical, bioanalytical, immunological, and compendial methodologies.
• Scientifically evaluate analytical methods, procedural changes, transfer strategies, validation approaches, and acceptance criteria to ensure methods are fit for purpose.
• Provide technical leadership for complex investigations, method troubleshooting activities, and root cause analyses.

Method Transfer & Validation

• Design, author, review, and execute method transfer protocols, validation protocols, technical studies, and summary reports.
• Lead implementation of new technologies and testing approaches to improve assay performance, robustness, efficiency, and data quality.
• Support transfer and qualification of analytical, bioassay, and immunological methods from development, external laboratories, and manufacturing sites.
• Evaluate method performance and identify opportunities for continuous improvement and standardization.

Bioassay & Immunology

• Provide technical expertise in biological and immunological assay methodologies including, but not limited to, ELISA, ligand-binding assays, cell-based potency assays, flow cytometry, cell culture techniques, and related bioanalytical technologies.
• Interpret complex biological and analytical data and communicate scientific conclusions to internal and external stakeholders.
• Support troubleshooting, optimization, qualification, and validation of bioassays and immunological methods.

Project Management & Collaboration

• Independently manage multiple projects and priorities while ensuring timelines are achieved.
• Collaborate cross-functionally with Quality Control, Analytical Development, Manufacturing Sciences, Regulatory Affairs, Quality Assurance, and external partners.
• Provide technical recommendations and scientific rationale supporting project decisions.
• Support resource planning, laboratory scheduling, and prioritization of departmental activities.

Documentation & Compliance

• Author and review protocols, reports, investigations, change controls, deviations, risk assessments, SOPs, assay forms, and technical documents.
• Maintain complete, accurate, and contemporaneous laboratory records in accordance with GMP requirements.
• Ensure compliance with applicable regulatory requirements, internal procedures, and laboratory safety programs.

Leadership & Mentoring

• Provide technical mentoring, coaching, and training to junior analysts.
• Review scientific work and provide constructive feedback to colleagues.
• Promote a culture of scientific excellence, collaboration, continuous learning, and quality compliance.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
Education

• Master's degree in Immunology, Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline with relevant industry experience;

Or

• Bachelor of Science (BSc) in Immunology, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemistry, or related scientific discipline with a minimum of seven (7) years of relevant industry experience.

A degree in Immunology or a related life science discipline is considered a strong asset.

Experience

• Minimum 5-7 years of experience supporting analytical method transfer, method validation, method verification, or analytical development activities within a regulated pharmaceutical, biopharmaceutical, biologics, or vaccine environment.
• Demonstrated experience leading complex scientific projects with minimal supervision.
• Experience authoring and reviewing technical protocols, reports, investigations, and GMP documentation.
• Experience supporting internal and external method transfers is highly desirable.

Technical Skills

• Strong understanding of analytical chemistry, biologics, and bioanalytical testing principles.
• Experience with bioassays, immunological assays, and biologics testing is highly desirable.
• Knowledge of ELISA, MSD, flow cytometry, ligand-binding assays, cell-based potency assays, cell culture, or related immunological techniques is considered an asset.
• Strong scientific data interpretation, troubleshooting, and problem-solving skills.
• Proficient understanding of GMP requirements and laboratory compliance expectations.
• Excellent written and verbal communication skills.
• Demonstrated leadership, initiative, project management, and mentoring capabilities.
• Ability to successfully complete a pre-employment medical assessment.

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.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. 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.