ABOUT US

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 looking for a Laboratory Analyst to join our Laboratory Services team where you will work on projects to analyse drugs, their metabolites and other analytes in biological fluids and pharmaceutical preparation. In the safety laboratory, you will perform day-to-day tasks, including sample analysis, maintenance, calibration, and QCs, while adhering to the Turn Around Time (TAT) requirements of the business and sponsors. Also, you will assist in the development of methods of analysis to deliver fully validated assays and document all procedures. In the analytical laboratory, you role will participate in the development, validation and subsequent LC-MS-MS or ELISA analysis of samples generated from clinical trials and will assist in report generation whilst maintaining meticulous, contemporaneous data recording.

Under the supervision of Laboratory Services Team Lead/Principal Scientist, you will ensure compliance with regulatory good practice and guidance requirements of GCP and ISO 17025: (2017) standards whilst communicating and liaising with team members and other stakeholders. You will be laboratory-focused, training will initially be provided in both the safety and analytical laboratories, prior to specialisation.

KEY ACCOUNTABILITIES

• Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., GCP, EMA and FDA requirements).
• Communicate the status of work being performed with the assigned Laboratory Team Lead/Principal Scientist, Laboratory Project Manager, and other team members and escalate where appropriate to the Laboratory Team Lead if TAT will not be achieved.
• Prepare chemicals, reagents, solutions and subsequently process samples generated in a clinical study for routine assay procedures in line with Standard Operating Procedures (SOPs) and Working Instructions (WI).
• Schedule and run samples using Analyst software, using LC-MS-MS techniques and Gen5 software, using Elisa techniques.
• Analyse safety samples and provide results that can be authorised by Biomedical Scientists or analysts certified as competent to release results.
• Perform routine calibration and Quality Control (QC) of safety instrumentation.
• Analyse, review, and trend monitor internal quality controls and external quality assessment schemes performances in the safety laboratory.
• Assist with or prepare the production of relevant documentation (protocols, procedures, validation/study reports, SOPs, CAPAs, file notes), helping to ensure documents are delivered to the client and archived within expected timeframes.
• Carry out general laboratory duties in order to ensure the efficient operation of the laboratory, such as logging of solvents, database maintenance and waste management.
• Maintain personal training records to demonstrate competency.

SKILLS REQUIRED

ESSENTIAL

• Working towards a Science degree or previous experience of working in a laboratory environment
• Previous experience in working with written instructions
• Good organisation skills with the ability to prioritise work and work to tight deadlines
• Experience in using general laboratory equipment such as pipettes, centrifuges, and balances
• Proficient in using Microsoft Office for documenting and analysing, and reporting data
• Ability to document process followed accurately in a contemporaneous manner
• Good communication skills

DESIRABLE

• BSc in Chemistry, Biochemistry, Biomedical Sciences, or analytical related degree
• Experience in working in a regulated environment (MHRA GCP for labs/ISO 17025 )
• Strong attention to detail, proven ability of managing multiple sample analyses
• Ability to use analytical systems such as HPLC/LC-MS-MS
• Ability to set up and use ELISA based assays.
• Experience in a pathology/safety laboratory
• Previous experience of working with LIMS systems
• Ability to perform quality control processes
• Track record of working within a team environment

WHY YOU SHOULD JOIN 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.