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
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Troubleshoot assay performance issues including matrix interference, parallelism and dilutional linearity
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Take scientific accountability for assigned studies: data integrity, regulatory compliance, and final reporting
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Review and approve protocols, validation reports, SOPs and study documentation
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Mentor scientists developing their immunoassay technique
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Represent Laboratory Services with clients, auditors and Sponsors, and support Business Development with technical input
Skills Required:
ESSENTIAL
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Extensive hands-on experience with plate-based immunoassays (ELISA) in a regulated laboratory environment (GCP, GLP and/or GMP)
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Experience with the Ella (SimplePlex) platform or equivalent automated immunoassay systems
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Proven track record leading assay development and validation for biomarker or cytokine panel work
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Strong understanding of immunoassay-specific validation parameters (parallelism, dilutional linearity, matrix interference)
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Demonstrable ability to review and approve technical documentation to GxP standard
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Experience managing study timelines and priorities under deadline pressure
DESIRABLE
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MSc or PhD in a relevant scientific discipline
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CRO or clinical trial experience
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Experience with multiplex cytokine panels
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Six Sigma / Lean or project management certification
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Experience supporting audits and regulatory inspections
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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.
