Principal Scientist in 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 tailor‑made 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, acting as a Subject Matter Expert with accountability for assigned bioanalytical studies and projects. The role is responsible for ensuring regulatory compliance and data integrity are maintained in line with company standards. You will lead the development and validation of bioanalytical assays, including ELISA‑based methods, to analyse drugs, metabolites, and other analytes in biological samples generated from clinical trials, while maintaining accurate and contemporaneous data records. Working closely with Project Managers and other Principal Scientists, you will ensure studies are appropriately planned, resourced, and executed against key performance indicators of time, cost, and quality. As an ambassador for Laboratory Services, you will represent the function both internally and externally, including client and vendor interactions, support business development activities, and contribute to the ongoing development of colleagues within the department.

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

• Science degree or equivalent
• Significant experience working within a regulated laboratory environment (e.g., MHRA GCP for labs, GLP or GMP)
• Significant experience in leading regulated studies to GCP, GLP and/or GMP guidelines
• Demonstrable ability to use and troubleshoot analytical processes/systems
• Demonstrable ability to develop and validate analytical methods
• Demonstrable ability to document laboratory information to a GXP standard
• Demonstrable ability to perform quality control processes
• Good organisation skills with the ability to prioritise work to meet deadlines
• Demonstrable experience in working to written instructions
• Excellent verbal and written skills, with the ability to tailor communication to a variety of internal and external stakeholders
• Track record of effective working within a team environment

DESIRABLE

• MSc, PhD in a relevant discipline
• Experience in research work and/or relevant experience gained using similar scientific and analytical techniques
• Experience in streamlining and improving operational processes
• Project management/Six Sigma/Lean certification
• Good understanding of MHRA Phase I Accreditation scheme requirements
• In-depth knowledge of laboratory testing in a GLP/GMP/GCP environment
• In-depth knowledge of Laboratory Information Management Systems

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.