As a Bioanalytical Principal Investigator, you will take care of 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.
What will you be doing?
- 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.
Who we're looking for
We're looking for a proactive and enthusiastic individual who enjoys working collaboratively within a team and is committed to delivering high-quality scientific work.
You'll also have:
- A degree in Biological Sciences, Biochemistry, Immunology, or equivalent relevant experience.
- Experience working in a GxP-accredited laboratory environment, preferably GLP or GCP.
- Experience with immunoassay platforms such as ELISA, ligand-binding assays, and MSD (desirable).
- An understanding of EMA and FDA bioanalytical method validation requirements.
- Strong communication skills, with the ability to present scientific findings clearly and confidently to both colleagues and clients.
- A quality-focused and detail-oriented approach, with a strong commitment to scientific integrity.
- The ability to work proactively, manage priorities effectively, and contribute positively to team objectives.
