Merthyr Tydfil, Mid Glamorgan Pharmiweb
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 seeking a Research Scientist to join our Laboratory Services Department. In this role, you will be responsible for carrying out laboratory tasks related to bioanalysis and/or safety studies as outlined in Protocols, Standard Operating Procedures, Work Instructions, regulations, and guidelines, following the principles of GCP/GCLP in relation to laboratories and Clinical Trials. Your responsibilities may include sample receipt, preparation, and analysis, as well as associated data recording and processing, along with general laboratory duties related to consumables, apparatus, equipment, and facility management. You will be expected to perform all tasks in accordance with company standards for timeliness, quality, and cost, and collaborate closely with the Senior Scientists, Principal Scientists, and other team members.

KEY ACCOUNTABILITIES

• Process samples (sample preparation) generated in clinical studies for routine assay procedures, including the preparation of associated chemicals, reagents, and solutions, all in line with Protocols, Standard Operating Procedures (SOPs) and Working Instructions (WI).
• Assist the Senior Scientist and/or Principal Scientist in activities related to sample analysis, recording all data in line with company expectations.
• Assist the Senior Scientist and/or Principal Scientist in activities related to method verification/validation in order to deliver fully validated assays with the support of the Senior Research Scientist and Principal Scientist.
• Carry out various general laboratory duties to ensure the efficient operation of the laboratory, such as sample management activities, solvent logs, database maintenance, and waste management.
• Perform or assist with the routine maintenance/calibration of instrumentation or equipment.
• 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.
• Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., 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 assigned work with the assigned Principal Scientist, Laboratory Project Manager, and other team members.
• Maintain personal training records to demonstrate competency.

SKILLS REQUIRED

Essential

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

Desirable

• Analytical Science degree, ideally holding a BSc in Chemistry or Biochemistry
• Experience working in a regulated environment (MHRA GCP for labs)
• Strong attention to detail, proven ability to manage multiple sample analyses
• Familiarity with the setup and use of HPLC/LC-MS-MS and/or ELISA systems and/or Safety Study analytical equipment
• Previous experience working with LIMS systems
• Ability to document laboratory information to a GXP standard, including preparation of analytical reports
• Ability to perform quality control processes.

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.