Senior Research Scientist - Clinical Analysis

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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 ROLE

We are looking for a Senior Research Scientist - Clinical Analysis to join our Laboratory Services Department where you will perform daily activities, which include maintenance, calibration, QCs, and all aspects of analysis within the Clinical Analysis Laboratory while adhering to the business and sponsors' Turn Around Time (TAT) requirements. You will lead and act as a point of contact for technical aspects of instruments and/or specialised cell techniques. You will work closely with the Clinical Analysis Team Lead, Laboratory Supervisor, and other team members.

You will ensure that high-quality results are delivered and meet regulatory requirements (GCP and GLP) and ISO 17025: (2017) standards and look to improve processes where necessary. You will also routinely assist in developing analysis methods to deliver fully validated assays and documentation of all procedures, ensuring that processes are performed as efficiently and economically as possible. This position will require shift and weekend work to be performed when required.

KEY ACCOUNTABILITIES

• Assist in developing analysis methods to deliver fully validated assays and documentation of all procedures.
• Works closely with Research Scientists, supporting and directing the required laboratory tasks.
• Support in the training and development of other Laboratory Services employees.
• Perform or oversee sample receipt and processing of samples from the Clinical Unit.
• Process or lead on the processing of samples within the Specialised Cell Technique Laboratory, including PBMCs.
• Schedule and analyse samples using the Laboratory Clinical Analysers and/or assess and perform process improvement for the associated procedures.
• Utilise the Clinaxys LIMS system to provide results that can be authorised by Biomedical Scientists or analysts certified as competent to release results or act as the competent analyst to authorise the release of Clinical Analysis data results throughout the clinical conduct of a study.
• Perform and document routine scheduled maintenance, data backup and troubleshoot instrumentation and equipment.
• Ensure that all laboratory work adheres to good practice regulations and guidelines with procedures undertaken in a clear, accurate and contemporaneous manner and applying Quality Control (QC) procedures to ensure their accuracy per the principles of ALCOA+.
• Communicate the status of work performed with the Clinical Analysis Team Lead, Laboratory Supervisor, and other team members.
• Prepare quality documentation (standard operating procedures, non-compliances, file notes etc.) within expected timeframes.
• Lead on process definition and refinement projects, including SOP authoring and related training.
• Analyse, review, and trend monitor internal quality controls and external quality assessment schemes' performances.
• Leads and acts as a point of contact for technical aspects of instruments and/or specialised cell techniques.
• Act as a coach and mentor within the team, and act as a stand-in for the Laboratory Supervisor when required.
• Oversee or carry out various general laboratory duties to ensure efficient operation, such as stock control and waste management.
• Maintain personal training records to demonstrate competency.

SKILLS REQUIRED

ESSENTIAL

• BSc Science Degree
• Experience in a Clinical Analysis Laboratory environment
• Ability to use Clinical Analysers
• Rudimentary ability to develop analytical methods using Clinical Analysers
• Ability to document laboratory information accurately in a contemporaneous manner
• Experience working to written instructions
• Good communication and 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

DESIRABLE

• Biomedical science degree that is IBMS Registerable
• HCPC registered Biomedical Scientist in blood science or multi-disciplinary (including haematology and biochemistry)
• Previous experience in working in a regulated environment (IS0 17025 15189 or MHRA GCP)
• Research work, pathology/safety/hospital laboratory placements and/or relevant experience gained using similar scientific and analytical techniques
• Experience in specialist cell techniques, including the preparation of PBMC samples
• Strong attention to detail, proven ability to manage multiple sample analyses
• Previous experience working with LIMS systems
• Ability to perform quality control processes

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.