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 looking for a Senior Research Scientist to join our Laboratory Services Department. In this role, you will be responsible for performing assigned laboratory duties related to bioanalysis and/or safety studies in compliance with Protocols, Standard Operating Procedures, Work Instructions, regulations, and guidelines following the principles of GCP/GCLP for laboratories and Clinical Trials. Your duties may include sample receipt, preparation, and analysis, along with associated data recording, processing, and reporting. You will also be responsible for general laboratory duties related to consumables, apparatus, equipment, and facility availability, presentability, quality, and function. Additionally, you will provide mentoring and training to Research Scientists and, when assigned and authorized, other Senior Research Scientists. It is important to carry out all duties in line with company expectations of time, quality, and cost. You will work closely with Principal Scientists and other team members.
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).
- Perform activities related to sample analysis and record, including reporting where requested, all data in line with company expectations.
- Work closely with Research Scientists on assigned projects, providing support and guidance, where appropriate, on the required laboratory tasks.
- Support the training and development of Research Scientists and, when assigned and authorised, other Senior Research Scientists.
- 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.
- Assist the Principal Scientist in method development/verification/validation activities to deliver fully validated assays.
- 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.
- Perform routine maintenance/calibration of instrumentation or equipment.
- Oversee or carry out various general laboratory duties to ensure efficient operation (e.g., database maintenance, waste management, etc.).
- 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 work status with the assigned Principal Scientist, Laboratory Project Manager, and other team members.
- Provide technical advice to business development and participate in laboratory-related discussions with Sponsors and Simbec-Orion employees.
- Maintain personal training records to demonstrate competency.
Skills Required
Essential
- BSc in Science related degree or equivalent
- Experience in working in a laboratory environment and using general laboratory equipment
- Ability to use analytical systems such as HPLC/LC-MS-MS and/or ELISA and/or Safety Study analytical equipment
- Rudimentary ability to develop analytical methods using HPLC/LC-MS-MS and/or ELISA or onboard new technology/assays for Safety Studies
- Ability to document laboratory information accurately in a contemporaneous manner
- Experience working to written instructions
- Good organisation skills with the ability to prioritise work to meet deadlines
- Track record of successfully working within a team environment
- Proficient with Microsoft Office for documenting, analysing and reporting data
- Good Communication skills
Desirable
- Analytical Science degree, ideally holding a BSc in Chemistry or Biochemistry
- Experience in working in a regulated environment (MHRA GCP, GLP or GMP)
- Ability to use and troubleshoot LC-MS-MS and/or ELISA analytical systems
- Ability to fully develop and validate analytical methods, e.g. using LC-MS-MS and/or ELISA
- Previous experience in bioanalysis supporting clinical trials in a contract research organisation work and/or relevant experience gained using similar scientific and analytical techniques
- Strong attention to detail and proven ability to manage multiple sample analyses
- Experience in the preparation of analytical reports in a GXP environment
- Previous experience working with LIMS systems
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.
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