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Senior Research Scientist

Employer
Simbec-Orion
Location
Merthyr Tydfil, United Kingdom
Salary
Competitive
Start date
1 Dec 2021
Closing date
31 Dec 2021

View more

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

Job Details

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.

Summary of the Position:

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 w ork on projects to analyse drugs, their metabolites and other analytes in biological fluids and pharmaceutical preparation . The role will be laboratory -focu sed, 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:
  • E nsure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., GCP , EMA and FDA requirements).
  • D ocument procedures undertaken in a clear, accurate and contemporaneous man ne r and apply Quality Control (QC) procedures to ensure their accuracy in accordance with the principles of ALCOA + .
  • C ommunicate the status of work being performed with the assigned Principal Scientist , Laboratory Project Manager and other team members .
  • D evelo p methods of analysis to deliver fully validated assays.
  • S upervise/oversee or p repare 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.
  • Ensure that samples have been scheduled or run u sing Analyst software (including the use of LC-MS-MS techniques and/or review of chromatographic data ) .
  • P erform routine maintenance/calibration of instrumentation or equipment.
  • P roduce relevant documentation such as protocols, procedures, validation/study reports , SOP's , CAPA's , file notes.
  • Provide technical advice to business development and participate in laboratory - related discussions with Sponsor s and Simbec -Orion employees .
  • M aintain personal training records to demonstrate competency and support in the train ing 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.).

Minimum Requirements:

Essential:
  • BSc Science Degree
  • Previous e xperience in working in a laboratory environment
  • Ability to develop and validate methods using LC-MS-MS
  • Good o rganisation s kills with the ability to prioritise work to meet deadlines
  • Good general laboratory skills , a bility to use general laboratory equipment such as pipettes, centrifuges, and balances
  • P roficient with Microsoft Office for documenting , analysing and reporting data
  • Ability to document laboratory information accurately in a contemporaneous manner
  • Good communication skills


Desirable:

  • BSc in Chemistry or related analytical degree
  • Previous experience in working in a regulated environment (MHRA GCP, GLP or GMP)
  • Strong attention to detail, proven ability of managing multiple sample analyses.
  • 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


Simbec Orion Job Profile - Senior Research Scientist.pdf

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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