Tech Transfer & Validation Manager
This vacancy has now expired
This is your chance to work for a company that is a pioneer in gene and cell therapy focussing on long-term curative treatments. With vast investment being made into the organisation and new build projects on the horizon this is the ideal time to join the team and establish yourself as a key team member. They are led by an experienced executive team that are leading them to a bright and exciting future.
The Main Responsibilities are:
- Develop Technical subject matter expertise in the Technical team and wider manufacturing operations.
- Project Leadership/ Management arid formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, Launch and subsequent lifecycle
- Responsible for Product Lifecycle Management activities including Process Validation of processes in line with ICHQ8-10.
- Lead and/or provide technical support using established problem-solving techniques for investigations into Quality Events, Customer Complaints and IMC Provide technical recommendations, co ordinate and execute CAPA’s.
- Management of Change Controls; Providing impact assessments as a Technical Functional, coordinating input and support from development if required. Lead/ Support and/or coordinate the action plans Include 8-12 main activities
- Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio pharmaceutical
- Extensive industrial experience in Pharma/Bio within a GMP regulated
- Demonstrated interpersonal skills with the ability to work cross-functionally both with internal and external partners.
- Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment and successfully gaining approval and launching new products commercially
- Knowledge of the Regulatory compliance requirements within Europe, Japan and the
- Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma
- Ability to manage, multiple, cross-functional projects to deliver against key project milestones and deadlines.
- Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.
- Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices
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