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.