PPD is currently looking to recruit a Scientist to be based on-site at one of our clients in Stevenage, Hertfordshire as part of contracted work from PPD.
The role of Scientist is to work in their Biopharm Central Testing Laboratory (BioCTL).
This role will work with minimal supervision, interpret analytical data in regards to acceptability and consistency and set up and maintain analytical instrumentation.
To perform analysis of samples submitted from both internal and external manufacturing sites
To examine e.g. manufactured product samples utilising a range of biological assays, in accordance with regulatory requirements and agreed schedules.
Provide information on biochemical methods, test specifications and sampling regimes, and the impact they may have on the product
To work with the line manager or designated analyst to interpret tests results as required.
To ensure that all records and test results are accurately prepared and checked, peer reviewed prior to submission for approval for authorisation and according to company, customer and regulatory requirements.
To participate in the validation of test methods and equipment used in analysis to meet regulatory requirements
Review and compilation of results
Performing work assignments accurately, timely and in a safe manner
Training on routine operation, maintenance and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines
Education to a Bachelors or higher level in Biochemistry or related subjects
At least 3 years of GxP experience
At least 2 years of demonstrated QC experience (sample preparation, sample analysis/testing, data review)
At least 1 year of proven aseptic technique (preferably cell based assays experience)
Has knowledge and understanding of biochemical techniques and analytical disciplines aligned to bioassays in the context of biopharmaceutical product release including but not limited to: Mammalian cell culture, Cell based potency bioassays including inhibition and proliferation assays, ELISA
Very good organizational, planning, communication (oral, written), and problem solving skills
Satisfactory administrative skills e.g., computer literacy including MS Office
The ability to write protocols and reports with minimum supervision
Excellent attention to detail
Be able to communicate effectively and follow detailed written and verbal instruction