Principal Scientist Merthyr Tydfil

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 are seeking a Principal Scientist to join our Laboratory Services team as a technical Subject Matter Expert supporting bioanalytical studies using ELISA and LC-MS/MS methodologies. You will lead the development, validation, transfer, and application of analytical methods, ensuring all activities are delivered in compliance with GCP, GLP, and/or GMP standards. The role requires strong technical expertise across immunoassay and mass spectrometry techniques, including method optimisation, troubleshooting complex analytical issues, and ensuring data integrity throughout the full study lifecycle. You will provide scientific oversight of studies, including data review, interpretation, and reporting to regulatory standards. You will also play a key role in study planning, resource management, and delivery against timelines, quality, and cost expectations. Working closely with senior stakeholders, you will drive continuous improvement of ELISA and LC-MS/MS workflows and laboratory processes, mentor scientific staff, and act as a technical escalation point across analytical platforms. As a senior representative of the function, you will contribute to business development activities and support the continued growth and technical capability of the Laboratory Services team.

Key Accountabilities:

• Provide technical advice to Business Development and participate in laboratory‑related discussions with auditors, Sponsors and Simbec‑Orion employees.
• Act as a Laboratory Services Ambassador for Simbec‑Orion, presenting at conferences, trade shows, and academic institutes whilst demonstrating the department's expertise.
• Coordinate analytical studies from client onboarding to final reporting with accountability for the study’s regulatory compliance and scientific integrity.
• Develop methods of analysis in order to deliver fully validated assays.
• Support in mentoring and developing colleagues within the Laboratory Services department.
• Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment (e.g. GCP, EMA and FDA).
• Document procedures undertaken in a clear, accurate and contemporaneous manner and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA+.
• Communicate the status of work performed with Laboratory Management, Laboratory Project Manager, and other team members.
• Produce or review/approve relevant documentation such as protocols, procedures, validation/study reports, SOPs, CAPAs, and file notes.
• Ensure all relevant study documents are delivered to the client and archived within expected timeframes.
• Ensure the required resources are available to properly perform research tasks and ensure efficient use of consumables and instrumentation.
• Maintain personal training records to demonstrate adequate competency for the position held associated responsibilities.

Skills Required

ESSENTIAL

• Degree in a relevant scientific discipline or equivalent experience; advanced qualification desirable.
• Extensive experience working with ELISA and/or LC‑MS/MS analytical techniques within a regulated laboratory environment (GCP/GCLP, GLP, GMP).
• Proven track record of leading regulated bioanalytical studies, including analytical method development, optimisation, validation, transfer, and routine sample analysis.
• Strong technical expertise in immunoassay and/or mass spectrometry platforms, including instrument setup, maintenance, troubleshooting, and performance optimisation.
• Strong understanding of bioanalytical method validation principles, assay performance characteristics, and regulatory expectations.
• Demonstrable ability to ensure data integrity, quality, and compliance with GxP standards throughout the study lifecycle.
• Experience reviewing, interpreting, and approving analytical data, validation reports, and study documentation to regulatory standards.
• Demonstrable experience implementing quality control processes and supporting continuous improvement initiatives within the laboratory.
• Proven ability to lead scientific projects, manage competing priorities, and deliver against tight timelines and quality expectations.
• Strong experience working to and interpreting protocols, SOPs, study plans, and regulatory guidelines.
• Excellent organisational, written, and verbal communication skills, with the ability to engage effectively with internal teams, clients, auditors, and external stakeholders.
• Demonstrable ability to mentor, support, and develop scientific staff within a collaborative laboratory environment.

DESIRABLE

• MSc or PhD in a relevant scientific discipline.
• Experience working within a CRO and/or clinical trial environment.
• Practical experience across both ELISA and LC‑MS/MS analytical platforms.
• Knowledge of MHRA Phase I Accreditation scheme requirements.
• Experience supporting process improvement, laboratory efficiency, or workflow optimisation initiatives.
• Project management and/or Lean/Six Sigma certification.
• Experience supporting regulatory audits, client inspections, and compliance activities.
• Experience contributing to business development, client interactions, or technical proposal support.
• Previous line management, mentoring, or technical leadership responsibility within a scientific team.

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.