Scientist – Method Validation Darlington, North East England, England
Job description
About CPI
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.
Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.
From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.
Why this role is important for CPI’s work
Due to the continued growth of the National Biologics Manufacturing Centre based in Darlington and the opening up of the new state-of-the-art RNA Centre of Excellence, we are looking to recruit two Scientists to support the method validation activities as part of technology transfer of processes into the RNA Centre.
As the Scientist, you will contribute to the new product introduction (NPI) activities to support the manufacturing of RNA therapeutics through the technology transfer and validation of analytical methods in line with cGMP principles and the business unit requirements.
You will work under technical supervision of your line manager and senior colleagues from the MSAT and QC teams, to support a range of activities and meet the business unit objectives.
Key tasks in the Scientist role will include (but are not limited to) the below:
- To set up, plan and execute experimental work related to the technology transfer (TT) and validation of analytical methods according to cGMP and ICH Q2 (R1) guidelines.
- To support the development and optimisation of analytical methods for RNA therapeutics drug substance (DS) and drug product (DP) as required by the project(s).
- To create and maintain documentation and records, e.g., equipment SOPs, equipment qualification, analytical methods, method validation protocols and reports.
To support the Quality and Formulation teams with the following:
- Laboratory design/layout and equipment/consumables ordering.
- Analytical equipment commissioning, qualification, calibration, and maintenance.
- Technology transfer and validation of drug product methods.
The person we are seeking
To be successful in this role, it is essential that you have:
At least a HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus relevant industrial experience- Or Educated to Degree level (or equivalent) in a Scientific/Engineering discipline.
- Foundation of technical knowledge and some underpinning knowledge in analytical characterisation of biopharmaceuticals as well as evidence of technical problem solving.
It would be great if you also had:
- Knowledge and practice of cGMP principles, with experience in the validation of analytical methods according to ICH Q2 (R1) guidelines.
- Practical experience with analytical techniques of biopharmaceuticals, e.g., agarose gel electrophoresis, qPCR, spectrophotometry, HPLC, compendial methods.
- Experience of handling DNA/RNA products in the laboratory.
- Experience of analytical testing and quality control principles for biopharmaceutical products.
- Understanding of the requirements to produce biopharmaceuticals.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
- Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
- Generous pension scheme
- Life assurance and accident insurance schemes
- Flexible working
- Learning and Development Opportunities
- Free parking
Find out more about our culture and benefits.
Additional information
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.
