Fraser Dove International · 3 days ago
Senior Vice President Technical Operations
Fraser Dove International is partnering exclusively with a dynamic life sciences organisation committed to developing next-generation cell-based immunotherapies. The Senior Vice President, Technical Operations will oversee all technical operations functions, ensuring seamless delivery from early development through commercialisation.
Responsibilities
Establish and drive the organisation’s technical operations mission, vision and long-term strategy
Lead and oversee all CMC functions, including Process Development, Analytical Development, Quality, Manufacturing, and Supply Chain
Provide technical leadership for early, clinical and commercial manufacturing of cell-based immunotherapies
Oversee CMC content development for regulatory submissions and act as a key liaison with global health authorities
Evaluate and optimise insourcing versus outsourcing strategies for manufacturing and supply chain activities
Partner with senior leadership across Research, Clinical, Regulatory, Business Development and Finance to align CMC operations with corporate strategy
Recruit, mentor and develop high-performing teams to support organisational growth and technical excellence
Qualification
Required
Proven success leading cross-functional CMC and Technical Operations teams within the biopharmaceutical industry
Deep understanding of cell therapy development, manufacturing, and commercialisation processes
Demonstrated capability in authoring and supporting CMC regulatory submissions and engagement with the FDA and other global regulatory agencies
Strong leadership skills with a collaborative, data-driven approach to decision-making
Expertise in cGMPs, quality systems and regulatory compliance
Excellent communication, influencing and stakeholder management abilities
Degree in biology, engineering or related discipline; MBA or PhD preferred
20+ years of relevant biopharmaceutical experience, including at least 10 years at executive level
Preferred
MBA or PhD preferred