Analyst II, Method Transfer Sciences (Biochemistry)

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.

Job Summary

Analyst II, Method Transfer Sciences (Biochemistry) serves as a technical resource supporting the transfer, validation, verification, and continuous improvement of analytical and biological test methods within a regulated laboratory environment.

The role supports a range of technologies including mass spectrometry, bioassays, immunological methods, and other analytical platforms while collaborating cross-functionally to ensure methods are fit for purpose and compliant with regulatory expectations.

Responsibilities

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

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

• Scientifically and practically evaluate analytical and biological methods, procedural changes, and validation strategies to ensure appropriate methodology is applied.
• Support implementation of new technologies and approaches that improve assay performance, sensitivity, robustness, and efficiency.
• Participate in transfer, verification, validation, and optimization of bioassays and immunological methods.
• Support execution of biological testing techniques including ELISA, ligand-binding assays, cell-based assays, flow cytometry, and related immunological methodologies where applicable.
• Interpret complex biological and analytical data and communicate conclusions effectively to stakeholders.
• Lead or independently execute analytical method validations, method improvements, and investigations, ensuring accurate documentation and regulatory compliance.
• Collaborate cross-functionally to communicate scientific rationale, validation approaches, and data interpretation clearly and effectively.
• Apply advanced knowledge of analytical, biological, and compendial methodologies with a strong understanding of applicable regulatory requirements.
• Contribute technical insight and innovative ideas to troubleshooting efforts and root cause investigations.
• Maintain complete, accurate, and contemporaneous laboratory records in accordance with Good Manufacturing Practices (GMP) and internal procedures.
• Have strong communication skills; ability to articulate effectively in both written and verbal forms.
• Have strong organizational and interpersonal skills and the ability to work collaboratively with others.
• Strong leadership capabilities, independence, and initiative.
• Ability to successfully complete a pre-employment medical assessment.
• Able to work flexible hours or shifts.

Education, Experience & Skills
Education
•    Master's degree in Immunology, Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, Analytical Chemistry, or a related scientific discipline with relevant laboratory experience.

Or

• Bachelor of Science (BSc) in Immunology, Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemistry, or related field with a minimum of five (5) years of relevant analytical, bioassay, immunology, or biopharmaceutical laboratory experience

Experience 
•    Demonstrated expertise in analytical and/or biological method validation, method transfer, qualification, and regulated laboratory environments.
•    Experience with bioassays, immunological assays, cell-based methods, or biologics testing is strongly preferred.
•    Knowledge of ELISA, MSD, flow cytometry, ligand-binding assays, cell culture, potency testing, or related techniques is considered an asset.
•    Understanding of proteins, antibodies, biologics, vaccines, and immunology principles is highly desirable.
•    Experience supporting GMP testing of biological products and associated regulatory expectations is considered an asset.

Technical Skills
•    Strong written and verbal communication skills, with the ability to explain complex scientific concepts to diverse audiences.
•    Proven ability to work with some autonomy while contributing effectively within a team environment.
•    Demonstrate strong organizational skills, including the ability to manage multiple priorities in a fast-paced, highly regulated environment.
•    Adhere to all laboratory safety requirements, including WHMIS, biohazard safety, and general laboratory safety practices.
•    Work collaboratively with internal stakeholders while demonstrating independence, initiative, and emerging leadership capabilities.
•    Maintain flexibility by working adjusted hours or shifts as operational needs require.

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.