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*Define the scope of the commercial strategy for oncology cell/gene therapy pipeline assets in order to provide guidance to R&D teams in prioritising opportunities and helping to set the strategic development.
*Lead early and late stage analytical development method qualification and transfer for Cell/Gene products.
*Ensure you are a technical leader and persuasive liaison to Clients, contractors and stakeholders guaranteeing quality checks and release criteria for clinical materials.
*Act as a liaison to senior management, cross-functional teams and external organisations.
*Provide data summaries for CMC/CTD documents for regulatory filings with US and EU regulatory agencies.
*Manage the Laboratory team and provide scientific leadership in analytical design and methods development during release and stability testing for Cell/Gene therapy products.
*Provide input for development and refinement of the company strategic vision and objectives for Cell/Gene therapy.
*Minimum of 8-10 years directly related experience in biotechnology or pharma industry.
*PhD in immunology, cell biology, molecular biology or equivalent field with preferred industry experience in Cell/Gene Therapy.
*Demonstrated leadership skills in working with cross functional teams.
*Have a broad understand of GMP, QC, GLP, FDA, EMA, and ICH regulatory requirements.
*Outstanding communication and organisational skills to demonstrated drive for results.
Do reach out to me at or +44 07771 976356