Seeking a Scientific Affairs and Technical Lead to oversee Technology Transfer, Process Validation, Cleaning Validation, Manufacturing Operations and R&D.
This key role reports to the Director of Technical and Scientific Affairs and oversees a team ensuring expertise in investigations, CAPAs, and process improvements.
Responsibilities
* Lead and develop the TSA team.
* Set and oversee team goals.
* Drive problem-solving and liaise with authorities on material imports.
* Implement new methods, manage technology transfers, and train production teams.
* Align processes with regulatory requirements.
* Contribute to company strategy and organisational planning.
* Provide professional support and represent the organisation in forums.
Requirements
* Master's degree in a technical field; PhD preferred.
* 10+ years in biotech/pharma, including new product introductions.
* 5+ years' leadership experience managing teams.
* Knowledge of pharmaceutical manufacturing (oral dose, parenterals, biologicals).
* Vaccine experience in product development preferred.
* Skilled in short- and long-term planning and prioritisation.
* Flexible, agile, and goal-oriented.
* Experienced in coaching technical teams.
* Strong problem-solving, risk management, and collaboration skills.