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 with advanced expertise in LC-MS/MS to join our Laboratory Services team as a technical Subject Matter Expert. You will lead the development, validation, and application of LC-MS/MS methods for bioanalytical studies, ensuring all activities are delivered in compliance with GCP, GLP, and/or GMP standards. The role requires deep technical knowledge of mass spectrometry, including method optimisation, troubleshooting complex analytical issues, and ensuring data integrity across the full study lifecycle. You will be accountable for the 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 LC-MS/MS workflows and laboratory processes, mentor scientific staff, and act as a technical escalation point. As a senior representative of the function, you will contribute to business development activities and support the growth and 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 scientific discipline or equivalent; advanced qualification desirable
-
Extensive experience using LC-MS/MS in a regulated laboratory environment (GCP, GLP, GMP)
-
Proven track record of leading LC-MS/MS-based studies, including method development, validation, and routine sample analysis
-
Deep technical expertise in mass spectrometry, including instrument setup, optimisation, maintenance, and troubleshooting
-
Strong understanding of bioanalytical method validation requirements and regulatory expectations
-
Demonstrable ability to ensure data integrity and compliance with GxP standards
-
Experience in reviewing and approving analytical data, reports, and study documentation
-
Proven ability to lead projects, manage priorities, and deliver to tight deadlines
-
Strong experience working to and interpreting protocols, SOPs, and regulatory guidelines
-
Excellent communication skills with the ability to engage internal teams, clients, and external stakeholders
DESIRABLE
-
MSc or PhD in a relevant discipline
-
Experience within a CRO or clinical trial environment
-
Knowledge of MHRA Phase I Accreditation scheme requirements
-
Experience in process improvement, operational efficiency, or workflow optimisation
-
Project management or Lean/Six Sigma certification
-
Experience supporting audits, inspections, and regulatory submissions
-
Line management or mentoring experience 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.
