Our Client, a global market leader in the biopharma industry currently requires the support of an experienced Tech Transfer Lead to support a high profile project. The successful candidate will be required to provide specialized technical, project management and leadership expertise in technology transfer of biologics Drug substance, Drug product and vaccines manufacture, delivered in accordance with overall project requirements.
• Responsible for the implementation, monitoring, controlling and management of activities in
accordance with the Tech transfer plan.
• Ensure effective planning & scheduling of activities, reporting of achievements and escalation
of issues and risks
• Coordinate activities and communication between SU and RU teams and to organizational
• Responsible for the coordination of overall scope, schedule and quality delivery for the
introduction of a new product to a site, manufacture and validation of the process, generation
of submission ready regulatory documents, approval and commencement/handover to
• Provision of leadership, mentoring and support in the Tech transfer process to the SU and RU
• Organize and coordinate SU activities, drive the compilation and consolidation of knowledge
transfer package and ensure effective management of knowledge transfer.
• Drive the generation of Technology Transfer program management documentation; plans,
schedules, resource plans, gap analysis, protocols etc. as required.
• Drive impact assessment of process or method adaptations proposed by RU and on process
and product comparability, ensure endorsement by SU operations.
• Facilitate and coordinate SU support to RU activities such as engineering runs, process and
analytical method implementation and validation, regulatory submission and inspections, and
post-transfer continued process verification and process ramp up activities.
• Ensure compliance of proposed solutions proposed at CMO to support product manufacture
• Coordinate information exchange and query resolution with the SU Technical team and other
LOA: 6 months up to 12 months
DPW: 5 Days per week, remote