QC Manager, Analytical Development
We are looking for a QC Manager to develop and run QC analytical methods to characterise product quality attributes of biopharmaceuticals.
Responsibilities:
- Develop QC analytical methodologies and create SOPs for product quality analysis of monoclonal antibodies and novel biologics to support the client’s portfolio.
- Technology Transfer to Contract Manufacturing Organisations.
- To provide CMC manufacturing records and documentation to support regulatory submissions.
- To communicate progress and identify risks and issues arising to the Group Leader of Analytical Development as appropriate.
- Represent the Analytical Development function on internal and external project teams.
- To maintain awareness of, and ensure compliance with the client’s policies and procedures.
Job requirements:
- PhD in relevant discipline or BSc/MSc with equivalent industrial experience.
- Proven track record of analysing product quality attributes for biopharmaceuticals.
- Proven track record in analytical method development for mAbs and biologics.
- Proven track record in maintaining CMC documentation within a Quality Management System.
Skills & knowledge:
- Comprehensive knowledge of qualifying (essential) and validating (desirable) analytical methods to support biopharmaceutical development.
- Highly competent in liquid chromatography (reversed-phase, size exclusion, IEX) and capillary electrophoresis technologies.
- Experience in mass spectrometry techniques, including peptide mapping and intact mass analysis, desirable.
- Ability to work independently to establish and run qualified/validated methods and to perform analytical testing as required.
- Highly organised, able to prioritise work, work well under pressure and meet deadlines
- Excellent communication and organisational skills
- Development and implementation of analytical capabilities
