Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is seeking an Analytical Validation Manager to be accountable 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.

Job Responsibilities:

• Accountable to lead the development and validation of established and novel analytical test methods for the current and newly developed gene therapy products.
• Generate qualification/validation projects and associated documentation in support of the analytical activities performed ensuring compliance requirements are maintained.
• Represent as the subject matter expert for lifecycle management of analytical assays, equipment and materials including in process samples and finished products.
• Support the setup 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 adheres 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.
• Accountable for the project management of test method implementation to required timescales to ensure seamless launch of new products.
• Maintain the flow of information to key stakeholders, ensure appropriate communications are passed forward and information folders are maintained with most recent versions/communications.
• Ensure the development and rollout of training on new technology/methodology introduced to the facility.

Key Skills:

• Proficiency in IT, Microsoft Office software (Word, Excel, Powerpoint) preferred.

Requirements:

• 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.