Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease, chikungunya and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees.
An opportunity has arisen at Valneva Scotland for a Deputy Head of Process Development.
To deputise for team management in the delivery of technical and scientific expertise for the development, optimisation and introduction of processes associated to manufacturing site operations for existing and proposed new products. Deputation for management of the development, delivery and implementation of improvement projects for robustness, consistency, success and enhanced outputs. To provide site wide technical and investigational support through data evaluation and laboratory work.
Deputise in the management of activities required to be performed by the Process Development team:
- Management of experienced scientists to ensure ownership and delivery of assigned project tasks, systems and areas of responsibility to agreed target dates
- Identify and manage delivery of process development / improvement projects, from conception to validation, with a view to increased process robustness, yield and success rate or reduced COGs to agreed timeframe
- Ensure the use of change management techniques and procedures for implementation where required.
- Ensure consideration of risk and implementation of strategy
- Manage and lead delivery of new process introduction where identified for business required
- Ensure development Proposals, Plans and Reports are generated with adequately identified commercial considerations, impacts and milestones for delivery
- Ensure work plans are aligned with business requirements and site projects, goals & objectives
- Deliver key critical data for the identification and mitigation of process risks or failure mechanisms through trending and escalation
- Provide site wide technical expertise, key role in troubleshooting and lead key technical investigations / assessments, utilising critical trended data to support on time delivery of Quality Investigations
- Support regulatory submissions by provision or review of technical reports and/or data
- Manage and track on time delivery of department owned Quality Management System actions and documentation
- Escalate deviations to compliance through senior site management
- Degree qualification or equivalent experience in biological sciences or related discipline
- Strong GxP understanding and experience
- Strong commercial awareness and demonstrable leadership
- Good understanding of working with Biological systems, equipment and environments
- Good experience of protein chemistry and characterisation
- Process / assay development experience of Biological systems, particularly viral products
- Good experience of statistical data analysis and process trending
- Experience of change management, lean systems and risk analysis
- Excellent communication and team management
- Concern for delivery
- Ability to work in fast paced environment with changing business priorities, managing conflicts to priorities
- Analytical thinking
- Team player with awareness of impact on people, process and systems