Our Mission:
Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.
We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
The Role:
We are seeking a Senior Research Scientist with strong ELISA expertise to join our Laboratory Services Department. You will be responsible for the delivery of ELISA-based bioanalytical and/or safety studies, including sample receipt, preparation, assay execution, and data analysis, ensuring full compliance with protocols, SOPs, and GCP/GCLP requirements. The role requires hands-on experience with ELISA techniques such as plate setup, reagent preparation, calibration curve generation, assay optimisation, and troubleshooting, alongside accurate and contemporaneous data recording and reporting. You will also support assay transfer and contribute to maintaining assay performance and consistency within a regulated environment.
In addition to analytical responsibilities, you will maintain laboratory readiness, ensuring ELISA equipment, consumables, and reagents meet quality and compliance standards. You will mentor junior scientists in ELISA methodologies and good laboratory practice, supporting capability development within the team. Close collaboration with Principal Scientists and other stakeholders is essential to ensure studies are delivered to agreed timelines, quality standards, and cost expectations.
Key Accountabilities:
- Supervise/oversee or undertake the processing of 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).
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Perform activities related to sample analysis and record, including reporting where requested, all data in line with company expectations.
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Work closely with Research Scientists on assigned projects, providing support and guidance, where appropriate, on the required laboratory tasks.
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Support the training and development of Research Scientists and, when assigned and authorised, other Senior Research Scientists.
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Assist with or undertake 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.
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Assist the Principal Scientist in method development/verification/validation activities to deliver fully validated assays.
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Perform or supervise the processing of samples using software, e.g. software for the routine processing of analytical batches using LC-MS-MS or ELISA techniques.
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Perform routine maintenance/calibration of instrumentation or equipment.
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Oversee or carry out various general laboratory duties to ensure efficient operation (e.g., database maintenance, waste management, etc.).
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Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment. (i.e., GCP, EMA and FDA).
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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+.
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Communicate the work status with the assigned Principal Scientist, Laboratory Project Manager, and other team members.
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Provide technical advice to business development and participate in laboratory-related discussions with Sponsors and Simbec-Orion employees.
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Maintain personal training records to demonstrate competency.
Skills Required:
Essential
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BSc in a relevant scientific discipline (e.g. Biochemistry, Biology, Biomedical Science) or equivalent experience
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Demonstrable hands-on experience performing ELISA assays, including plate preparation, assay execution, and data analysis
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Strong working knowledge of immunoassay principles, including calibration curves, controls, sensitivity, specificity, and assay performance characteristics
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Experience working in a laboratory environment using standard laboratory equipment and good laboratory practices
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Proven ability to troubleshoot ELISA assays and resolve technical issues to maintain data quality
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Experience in generating, recording, and verifying laboratory data in a contemporaneous and GxP-compliant manner
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Ability to follow and interpret protocols, SOPs, and work instructions accurately
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Strong organisational skills with the ability to manage multiple assays and prioritise competing deadlines
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Demonstrable experience working collaboratively within a team environment
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Proficient in Microsoft Office (particularly Excel) for data analysis, interpretation, and reporting
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Effective written and verbal communication skills
Desirable
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Degree in Analytical Science, Biochemistry, or related discipline
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Experience working in a regulated environment (GCP, GLP, GMP)
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Experience in ELISA method optimisation, transfer, and/or validation
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Exposure to bioanalysis supporting clinical trials, ideally within a CRO environment
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Familiarity with LIMS and electronic data capture systems
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Experience preparing analytical or study reports to GxP standards
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Strong attention to detail with proven ability to manage high sample throughput
About Us:
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to 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 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.
