Simbec Orion Group
Merthyr Tydfil, Mid Glamorgan
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 our small molecule LC-MS/MS bioanalysis, working across oncology, rare disease and clinical pharmacology studies. You'll take ownership of method development and validation on triple quadrupole platforms, troubleshoot complex extraction and chromatographic issues, and act as the technical authority for the studies you run, from client onboarding through to final report. This is a hands-on technical role with real scientific ownership. You'll set the direction on method strategy, mentor the wider team on LC-MS/MS technique, and represent Laboratory Services in front of clients, auditors and inspectors. Key Accountabilities Lead LC-MS/MS method development and validation, from extraction strategy through to fully validated assay Troubleshoot instrument and method issues, acting as technical escalation point for the team 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 LC-MS/MS technique Represent Laboratory Services with clients, auditors and Sponsors, and support Business Development with technical input Skills Required ESSENTIAL Extensive hands on experience with LC-MS/MS (triple quadrupole) in a regulated laboratory environment (GCP, GLP and/or GMP) Proven track record leading method development and validation for small molecule bioanalysis Strong grounding in extraction technique (protein precipitation, LLE, SPE) and chromatographic troubleshooting Working knowledge of current bioanalytical method validation guidance 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 Familiarity with MHRA Phase I Accreditation requirements 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.
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 our small molecule LC-MS/MS bioanalysis, working across oncology, rare disease and clinical pharmacology studies. You'll take ownership of method development and validation on triple quadrupole platforms, troubleshoot complex extraction and chromatographic issues, and act as the technical authority for the studies you run, from client onboarding through to final report. This is a hands-on technical role with real scientific ownership. You'll set the direction on method strategy, mentor the wider team on LC-MS/MS technique, and represent Laboratory Services in front of clients, auditors and inspectors. Key Accountabilities Lead LC-MS/MS method development and validation, from extraction strategy through to fully validated assay Troubleshoot instrument and method issues, acting as technical escalation point for the team 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 LC-MS/MS technique Represent Laboratory Services with clients, auditors and Sponsors, and support Business Development with technical input Skills Required ESSENTIAL Extensive hands on experience with LC-MS/MS (triple quadrupole) in a regulated laboratory environment (GCP, GLP and/or GMP) Proven track record leading method development and validation for small molecule bioanalysis Strong grounding in extraction technique (protein precipitation, LLE, SPE) and chromatographic troubleshooting Working knowledge of current bioanalytical method validation guidance 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 Familiarity with MHRA Phase I Accreditation requirements 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.