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Research Scientist

Employer
Simbec-Orion
Location
Merthyr Tydfil, United Kingdom
Salary
Competitive
Start date
16 Jun 2022
Closing date
28 Jun 2022

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Discipline
R & D , Laboratory
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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 JOB

We are looking for a Research Scientist to join our Laboratories department in Merthyr Tydfil (Wales).

You will work on projects to analyse drugs, their metabolites and other analytes in biological fluids and pharmaceutical preparation. The role will be laboratory-focused, participating in the development, validation and subsequent LC-MS-MS analysis of samples generated from clinical trials, and subsequently required to assist in report generation whilst maintaining meticulous, contemporaneous data recording. You will ensure compliance with regulatory good practice and guidance requirements within set timeframes and will work closely with the Laboratory Project Lead, Principal Scientist and other team members.

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).
  • 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 being performed with assigned Principal Scientist, Laboratory Project Manager, and other team members.
  • 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 i.e., the routine processing of analytical batches using LC-MS-MS techniques.
  • Schedule and run samples using Gen5 software i.e., the routine processing of analytical batches using Elisa techniques.
  • Assist in the development of methods of analysis in order to deliver fully validated assays.
  • Assist with or prepare the production of relevant documentation (protocols, procedures, validation/study reports, SOP's, CAPA's, file notes) helping to ensure documents are delivered to the client and archived within expected timeframes.
  • Carry out various general laboratory duties in order to ensure the efficient operation of the laboratory, such as logging of solvents, database maintenance and waste management.
  • Perform or assist with the routine maintenance/calibration of instrumentation or equipment.
  • Maintain personal training records, to demonstrate competency.

SKILLS REQUIRED

Essential:
  • BSc in Science related degree or working towards a Science degree.
  • Experience in working in a laboratory environment
  • Experience of working to written instructions
  • Good Organisation Skills with the ability to prioritise work
  • Experience of 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
  • An ability to work to tight deadlines

Desirable:

  • Analytical Science degree, ideally holding BSc in Chemistry
  • Experience of working in a regulated environment (MHRA GCP for labs)
  • Strong attention to detail, proven ability of managing multiple sample analyses
  • Ability to set up and use HPLC system.
  • Ability to use analytical systems such HPLC/LC-MS-MS
  • Previous experience of working with LIMS systems
  • Ability to document laboratory information to a GXP standard, including preparation of analytical reports
  • 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.

Simbec Orion Job Profile - Research Scientist.docx


Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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