- Provide end-to-end oversight of multiple regulated Immunoassay bioanalytical studies under GLP/GCP.
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Robust scientific decision making in accordance with the EMA and FDA regulatory guidance’s
- Oversee method validation and sample analysis activities with scientific authority.
- Serve as primary contact for clients, building strong partnerships and supporting programme progression.
- Consistent on time delivery of high-quality data and study reports to your customers.
- Adapt flexibly to challenges, identifying solutions to complex analytical and regulatory customer problems.
- Mentor and guide scientists within the Immunoassay team, promoting scientific excellence and continuous improvement.
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Degree in Biological Sciences, Biochemistry, Immunology, or equivalent relevant experience.
- Experience working in a GxP-accredited laboratory, preferably GLP or GCP
- Experience with immunoassay platforms (e.g., ELISA, ligand-binding assays, MSD) is advantageous.
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Understanding of EMA and FDA bioanalytical method validation requirements.
- Skilled communicator able to present scientific outcomes clearly to colleagues and clients.
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Proactive, enthusiastic, quality-driven, and detail-focused, with a commitment to scientific integrity.
As a Bioanalytical Principal Investigator, you will assume full scientific and regulatory responsibility for assigned bioanalytical studies, ensuring delivery of high‑quality, compliant data. You will lead the design, development, validation, and execution of immunoassay methods and manage sample analysis phases across GLP and GCP .
Working closely with clients, laboratory teams, and quality functions, you will provide scientific leadership, robust decision‑making, and expert guidance across a diverse portfolio of regulated projects.
