Analyst III, Method Transfer Sciences; Biochemistry

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Location:

Winnipeg, MB, CA, R3T 5Y3

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.

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.

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

• 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.

• 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.
• 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.
• 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.

• 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.
• 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.

• 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,…