Analytical Validation Manager
Brilliant Opportunity in central London to support a rapidly growing Gene Therapy company with their transition into commercial manufacturing.
The Analytical Validation manager will be responsible for the validation and technology transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU and FDA GMP requirements. The role involves life cycle management of assays, equipment and materials/products.
- Lead the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
- Serve as the subject matter expert for life-cycle management of analytical assays, equipment and materials including in process samples and finished products.
- Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained.
- Support the set up of the QC department for the continuation of the analytical testing for clinical trial materials, commercial supply and stability studies.
- Ensure all methods are validated and performed in the QC GMP labs in compliance to regulatory standards and adhere to data integrity requirements.
- Generate master QCAR documents and implement to support all analytical methods. Ensure these are current.
- Develop and maintain stability programs for materials and products
- Degree in Human Health or Sciences equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics).
- Demonstrate significant experience in an analytical development and validation role in the pharmaceutical or other regulated industry.
- Proficiency in a body of information required for the job e.g knowledge of EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, Six-Sigma, etc.
- Proficiency in IT, Microsoft Office software (Word, Excel, Powerpoint) preferred.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
QA Manager – Start Up Biotech Company – London – Permanent Our growing Bio-pharmaceutical client who are seeking to deliver truly innovative, life-changing therapies for their patients are
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