Senior Scientist
1 month ago
We are seeking an Associate Principal Development Scientist - Cell Processing and Gene Modification Lead to join our team. This senior position has a significant hands-on component and is responsible for providing leadership to the Process Development Cell Processing and Gene Modification Team within Process Development.
Key Responsibilities:
• Provide vision and strategic scientific leadership in a hands-on setting, sharing cell culture work and providing practical technical SME support to others in the Process Development Cell Processing and Gene Modification team.
• Ensure strategic alignment with the Chief Scientific and Technology Officer, Innovation, and QC departments.
• Develop cell product manufacturing unit operations, including apheresis processing, target cell selection, cell differentiation or activation, cell engineering, delivery methods (e.g., electroporation), cell expansion, harvest, formulation, and cryopreservation.
• Collaborate with Business Development to scope/cost new projects and win new business.
• Develop plans for method development, transfer, and qualification.
• Stay abreast of global Cell and Gene Therapy/Sterile Manufacturing regulatory guidelines and trends.
• Formulate realistic, tangible plans and solutions aligned with multi-project deliverables.
• Directly manage Cell Processing and Gene Modification Scientists, including recruitment, training, and performance management.
• Ensure quality, compliance, and good laboratory practices (non-GMP and GMP).
• Manage change, including work patterns, project scopes, and ad hoc events.
• Review technical reports, investigations, complex change controls, deviations, and risk assessments.
• Promote high standards of good laboratory practices and technical report writing.
• Own and influence policies and procedures relevant to your area of responsibilities.
• Maintain professional communication with colleagues, client representatives, and the wider scientific community.
Requirements:
• Hands-on experience in Cell and Gene Therapy cell process development and current technologies.
• Familiarity with cell product manufacturing unit operations, including apheresis processing, target cell selection, cell differentiation or activation, cell engineering, delivery methods (e.g., electroporation), cell expansion, harvest, formulation, and cryopreservation.
• Exceptional organisational, time management, and computer skills (Microsoft Word and Excel).
• A Life Sciences Degree, Master, or PhD in a related subject, with previous experience in a CDMO manufacturing-focused environment.
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