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 Senior Research Scientist to join our Laboratories department. You will be based in our offices in Merthyr Tydfil, UK.
You will work on projects to analyse drugs, their metabolites and other analytes primarily in biological fluids. The role will be laboratory-focused, participating in the development, validation and subsequent LC-MS-MS analysis of samples generated from clinical trials, whilst maintaining meticulous, contemporaneous data recording. You will support with the supervision of Laboratory Services Scientist to ensure compliance with regulatory good practice and guidance requirements within set timeframes. KEY ACCOUNTABILITIES
- Participate in developing methods of analysis to deliver fully validated assays.
- Supervise/oversee or prepare chemicals, reagents, solutions and process samples generated in a clinical study for routine assay procedures as described in Standard Operating Procedures (SOPs) and Working Instructions.
- Perform or supervise the processing of samples using Analyst software, i.e., routine processing of analytical batches using LC-MS-MS techniques, including review of chromatographic data.
- 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 work being performed with the assigned Principal Scientist, Laboratory Project Manager and other team members.
- Provide technical advice to business development and participate in laboratory-related discussions with Sponsors and Simbec-Orion employees.
- Produce relevant documentation such as protocols, procedures, validation/study reports, SOP's, CAPA's, file notes.
- Perform routine maintenance/calibration of instrumentation or equipment.
- Maintain personal training records to demonstrate competency and support in the training and development of other Laboratory Services employees.
- Carry out various general laboratory duties in order to ensure the efficient operation of the laboratory (i.e., database maintenance, waste management, etc.).
WHY YOU SHOULD JOIN US
- BSc Science Degree
- Experience in working in a laboratory environment
- Ability to use analytical systems such HPLC/LC-MS-MS
- Rudimentary ability to develop analytical methods using HPLC/LC-MS-MS
- Ability to document laboratory information accurately in a contemporaneous manner.
- Experience of working to written instructions
- Good organisation skills with the ability to prioritise work to meet deadlines
- Track record of working within a team environment
- Proficient with Microsoft Office for documenting, analysing and reporting data
- Good Communication skills
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. our clinical pharmacology site, or laboratory services. We're waiting to hear from you.
Simbec Orion Job Profile - Senior Research Scientist-01Mar2022.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.