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Lab Scientist - Merthyr Tydfil, Wales, United Kingdom - Simbec-Orion
Description
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases.
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.
We are looking for a Principal Scientist to join our Laboratory Services team where you will be a key part of the Laboratory Services team, leading Bioanalytical studies to analyse drugs, their metabolites, and other analytes primarily in biological fluids.
The Principal Scientist is accountable for regulatory compliance and scientific integrity.In addition, the role will develop and validate subsequent Bioanalytical assays using ELISA-based analysis for samples generated from clinical trials whilst maintaining meticulous, contemporaneous data recording.
The Principal Scientist will interact with the Project Manager on a daily basis to ensure all study tasks are executed and will frequently represent the business with the client and other third-party vendors.
Develop methods of analysis in order to deliver fully validated assays.Coordinate analytical studies from client onboarding to final reporting with accountability for the study's regulatory compliance and scientific integrity.
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 Immunoassay techniques and commercially available quantification software, e.g., Gen5 software, including review of raw data.
Supervise or process samples within the Specialised Cell Technique Laboratory, including but not limited to PBMCs and cell stimulation.
Ensure that work performed adheres to good practice regulations and guidelines associated with a laboratory environment.(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 performed with Laboratory Management, Laboratory Project Manager, and other team members.Provide technical advice to business development and participate in laboratory-related discussions with auditors, Sponsors and Simbec-Orion employees.
Ensure the required resources are available to properly perform research tasks and ensure efficient use of consumables and instrumentation.
Support in mentoring and developing colleagues within the Laboratory Services department.Maintain personal training records to demonstrate competency.
BSc Science Degree
Experience working in a regulated laboratory environment (e.g., MHRA GCP for labs, GLP or GMP)
Ability to document laboratory information to a GXP standard
Ability to perform quality control processes
Proficient in using Microsoft Office for documenting and analysing, and reporting data
Previous experience in managing studies in a regulated laboratory environment (MHRA GCP for labs, GLP or GMP)
Previous experience in bioanalysis supporting clinical trials in a contract research organisation work and/or relevant experience gained using similar scientific and analytical techniques
Previous experience in mentoring and developing junior colleagues
Strong attention to detail and proven ability to manage multiple sample analyses
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.
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.
