- 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. (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 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.
- Produce or review/approve relevant documentation such as protocols, procedures, validation/study reports, SOP's, CAPA's, and file notes.
- Ensure all relevant study documents are delivered to the client and archived within expected timeframes.
- Ensure the required resources are available to properly perform research tasks and ensure efficient use of consumables and instrumentation.
- Perform routine maintenance/calibration of instrumentation or equipment.
- Support in mentoring and developing colleagues within the Laboratory Services department.
- Maintain personal training records to demonstrate competency.
SKILLS REQUIRED
ESSENTIAL- BSc Science Degree
- Experience working in a regulated laboratory environment (e.g., MHRA GCP for labs, GLP or GMP)
- Ability to use and troubleshoot ELISA analytical systems
- Ability to develop and validate analytical methods using ELISA
- Ability to document laboratory information to a GXP standard
- Ability to perform quality control processes
- Good organisation skills with the ability to prioritise work to meet deadlines
- Experience working to written instructions
- Good Communication skills
- Track record of working within a team environment
- Proficient in using Microsoft Office for documenting and analysing, and reporting data
DESIRABLE- Higher degree in an analytical-related subject
- 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
- Experience validating ELISA analytical methods in biological fluids to EMA and FDA guidelines
- Ability to troubleshoot analytical method issues
- Experience in the preparation of analytical reports in a GXP environment
- Previous experience in mentoring and developing junior colleagues
- Experience in streamlining and improving operational processes
- Strong attention to detail and proven ability to manage multiple sample analyses
- Previous experience working with LIMS systems
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. -
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Description
ABOUT USSimbec-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 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.
KEY ACCOUNTABILITIES
