The Role
We are seeking a Research Scientist to join our Laboratory Services Department, supporting bioanalytical and/or safety studies using ELISA and LC-MS/MS methodologies within a regulated laboratory environment. In this role, you will carry out laboratory activities in accordance with Protocols, Standard Operating Procedures, Work Instructions, regulatory requirements, and the principles of GCP/GCLP relating to laboratories and Clinical Trials. Responsibilities will include sample receipt, preparation, extraction, and analysis, alongside associated data recording, processing, and reporting activities. You will also support routine laboratory operations, including the management of consumables, reagents, analytical equipment, and general laboratory readiness.
The role requires a strong focus on accuracy, data integrity, and compliance, ensuring all activities are performed to company standards for quality, timeliness, and cost. You will work closely with Senior Scientists, Principal Scientists, and wider laboratory teams to support the successful delivery of studies, while contributing to the maintenance of high scientific and operational standards across ELISA and LC-MS/MS workflows.
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.
Essential Skills Required
* BSc in a relevant scientific discipline or equivalent laboratory experience
* Experience working within a laboratory environment, preferably supporting bioanalytical and/or safety studies
* Experience following protocols, Standard Operating Procedures, and written instructions accurately
* Good organisational skills with the ability to prioritise workload, manage multiple activities, and work to tight deadlines
* Experience using standard laboratory equipment such as pipettes, centrifuges, balances, and other general laboratory apparatus
* Proficient in Microsoft Office applications, particularly Excel, for documenting, analysing, and reporting data
* Ability to accurately document laboratory activities, processes, and data in a contemporaneous manner
* Strong attention to detail and commitment to producing accurate, high-quality work
* Good verbal and written communication skills with the ability to work effectively within a team environment
Desirable Skills
* Degree in Analytical Science, Chemistry, Biochemistry, Biomedical Science, or related discipline
* Experience working within a regulated environment (e.g. MHRA GCP for laboratories, GLP, GMP)
* Experience supporting ELISA and/or LC-MS/MS analytical techniques and associated laboratory processes
* Familiarity with the setup, operation, and routine maintenance of HPLC/LC-MS/MS and/or ELISA systems and/or Safety Study analytical equipment
* Proven ability to manage multiple sample analyses while maintaining accuracy and quality standards
* Experience using LIMS or other laboratory data management systems
* Ability to document laboratory information and analytical activities to GxP standards, including preparation of analytical reports
* Experience performing quality control activities and supporting laboratory compliance processes
* Exposure to sample preparation, extraction techniques, and routine bioanalytical workflows
#J-18808-Ljbffr