Principal Scientist

Simbec-Orion Group; Merthyr Tydfil; On-site; GBP 70,000 - 95,000; Full time

Job summary

Simbec-Orion Group is seeking a Principal Scientist to lead immunoassay and biomarker work within Laboratory Services. You will own assay development and validation, troubleshoot complex panels, and act as technical authority for client studies.

This role informs patient stratification and treatment response data and includes mentoring the team and representing the service in client and regulatory discussions.

Qualifications

• Extensive hands-on ELISA experience in a regulated lab (GCP/GLP/GMP).
• Ella (SimplePlex) platform experience or equivalent automated systems.
• Proven track record leading assay development and validation for biomarker/cytokine panels.
• Strong validation parameter knowledge: parallelism, dilution, matrix interference.
• Ability to review technical docs to GxP standard and manage study timelines.

Responsibilities

• Lead immunoassay development and validation across ELISA and Ella platforms.
• Troubleshoot assay performance issues (matrix interference, parallelism, dilutional linearity).
• Own studies: data integrity, regulatory compliance, final reporting.

Skills

ELISA immunoassays

Immunoassay validation

GxP documentation review

Study timelines management

Mentoring immunoassay team

Education

MSc or PhD in a relevant scientific discipline

Tools

Ella (SimplePlex) platform

Job description

Our Mission

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

The Role

We're looking for a Principal Scientist to lead immunoassay and clinical biomarker work within our Laboratory Services team, using platforms including ELISA and Ella (SimplePlex) to support studies across oncology, rare disease and clinical pharmacology. You'll take ownership of assay development and validation, troubleshoot complex biomarker and cytokine panel work, and act as the technical authority for the studies you run.

This role sits close to the clinic, your work directly informs patient stratification and treatment response data. You'll mentor the wider team on immunoassay technique and represent Laboratory Services in front of clients, auditors and inspectors.

Key Accountabilities

• Lead immunoassay development and validation across ELISA and Ella (SimplePlex) platforms
• Troubleshoot assay performance issues including matrix interference, parallelism and dilutional linearity
• Take scientific accountability for assigned studies: data integrity, regulatory compliance, and final reporting
• Review and approve protocols, validation reports, SOPs and study documentation
• Mentor scientists developing their immunoassay technique
• Represent Laboratory Services with clients, auditors and Sponsors, and support Business Development with technical input

Skills Required

ESSENTIAL

• Extensive hands-on experience with plate-based immunoassays (ELISA) in a regulated laboratory environment (GCP, GLP and/or GMP)
• Experience with the Ella (SimplePlex) platform or equivalent automated immunoassay systems
• Proven track record leading assay development and validation for biomarker or cytokine panel work
• Strong understanding of immunoassay-specific validation parameters (parallelism, dilutional linearity, matrix interference)
• Demonstrable ability to review and approve technical documentation to GxP standard
• Experience managing study timelines and priorities under deadline pressure

DESIRABLE

• MSc or PhD in a relevant scientific discipline
• CRO or clinical trial experience
• Experience with multiplex cytokine panels
• Six Sigma / Lean or project management certification
• Experience supporting audits and regulatory inspections
• Mentoring or informal line management experience

About Us

Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company – and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.