Head of Analytical Development
Head of Analytical Development (nucleic acids)Permanent Competitive Salary London, UK
Do you have experience from within a Biological Production, Manufacturing or Process environment?
My client are an award winning Biotechnolotgy Company, with state of the art, modern laboratories. They are revolutionising the way biomolecules are manufactured, and to due to continued investment and growth, are looking to hire a Head of Analytical Development.
The successful candidate will be leading the development of methods for the characterisation and analysis of nucleic acids, as well as the validation and transfer of methods into regulated operations.
- Provide strategic leadership and technical expertise to identify, develop and qualify/validate methodology suitable for the phase appropriate characterisation, release and stability testing of both internal and external nucleic acid-based products
- Participate in discussions with clients regarding specific analytical method development requirements
- Perform routine analytical research activities
- Troubleshooting related to analytical methods, stability studies, and investigations of anomalous results
- Technical and quality oversight of outsourced analytical development, characterisation and validation activities undertaken by selected analytical suppliers
- Preparation and review of Specifications, Method of analysis procedures and Analytical development reports
- Preparation of analytical technical documents for dossier, method transfer, and submissions of projects, for both internal and client projects
- Bachelor's Degree in the following fields of study: Biology, Biomedical Engineering, Biotechnology, Biochemistry, Chemical Engineering, Chemistry
- Substantial working experience in analytical development for Biologics or nucleic acids (7+ years desirable) in a CDMO environment
- Extensive Experience in a GMP Regulated, Pharmaceutical industry
- Strong conceptual, analytical development and validation skills
- Experience in drafting analytical documents for regulatory submission
This is an exciting opportunity to join a young dynamic biotech company working at the forefront of Molecular Manufacturing. Please apply online, email firstname.lastname@example.org or call 0203 0964529 for further information.
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