Regulated Study Manager- Immunoassay

Responsibilities

• Provide 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 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.

Skills, Education & Qualifications

• 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.
• 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.

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