Role: QC Analytical Scientist
Russell Taylor Group have a fantastic opportunity for an experienced analyst, who has worked within the pharmaceutical or medical industry, to join an expanding biotechnology company who specialise within oncological drug development.
- Take the lead role in the development and validation of Capillary electrophoresis-based assays for Antibodies and Antibody Drug Conjugates
- Performance and reporting of analytical testing on, intermediates, finished products and stability samples in capillary electrophoretic methods
- Preparation and execution of laboratory protocols and reports, as assigned.
- Qualification of reagents and reference materials,
- Acting as Subject matter expert at cross- functional project meetings
- In addition, following the completion of training and qualification, the performance of Analytical testing using a variety of techniques including:
- HPLC (SEC, HIC, PLRP etc);
- spectrophotometry; FTIR and UV - vis;
- Performance of routine tasks and other none routine activities required in support of quality control laboratory functions.
- Ensuring all testing performed is reported within the most efficient timeframe.
- Laboratory maintenance- housekeeping, self-inspections and stock control - support the re-order systems and communication with key suppliers.
- Data trending and performance of quality investigations
- Documentation of laboratory results in accordance with cGMP and company procedures.
- Ensure training status compliant with matrix requirements and to assist in training of laboratory and production staff.
- Maintain and improve knowledge of analytical techniques and procedures
- Contribute to team building, training and problem-solving initiatives internally and cross site.
- Liaise with functional groups both within and outside QC as appropriate to ensure projects and plans are progressed
- Ensuring that all laboratory activities are in compliance with all Health & Safety Guidelines, with particular reference to COSHH and Biological Safety Regulations and Health & Safety at Work Act 1974.
- BSc or equivalent qualification in a relevant Chemistry/ Biological subject area.
- At least 4 years' experience in an analytical testing laboratory and experience of working in a regulated environment, pharmaceutical or medical laboratory in a related role to cGMP or within alternative quality system (UKAS/ISO 9001) such as Contract testing laboratory.
- Technical experience in Capillary Electrophoresis analysis of Biomolecules is essential.
- Technical experience in techniques such as HPLC, Cell culture, Immunoassays, UV,MS is an advantage.
- Good understanding and application of cGMP and regulatory requirements including USP, PhEur, Orange guide and Current ICH guidelines applicable to the role.
- Excellent communication / interpersonal and organisational skills, demonstrating attention to detail and be able to work in a team and individually.
Key Words: Biotechnology, Capillary electrophoresis-based assays, HPLC, cGMP, Immunoassays, ELISA, Validation, Development, Antibodies.