QC Manager, Analytical Development
- Experience Level
If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders.
Our client is looking for a QC Manager to develop and run QC analytical methods to characterise product quality attributes of biopharmaceuticals.
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 (CMOs).
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.
Education & Experience
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 (monoclonal antibodies & novel biologics).
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 organizational skills
Development and implementation of analytical capabilities
Maintain a high standard of professionalism when representing the Company both internally and externally
Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external CMOs
Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: email@example.com . We endeavour to come back to you within 24 hours of CV submission.