Regulated Study Manager- Immunoassay

Job Description ResponsibilitiesProvide end-to-end oversight of multiple regulated Immunoassay bioanalytical studies under GLP/GCP.Robust scientific decision making in accordance with the EMA and FDA regulatory guidances 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.Skills, Education & QualificationsDegree 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.Understanding of EMA and FDA bioanalytical method validation requirements. Skilled communicator able to present scientific outcomes clearly to colleagues and clients.Proactive, enthusiastic, quality-driven, and detail-focused, with a commitment to scientific integrity.

Created: 2026-03-20