Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 600 employees.
We have a new opportunity within our Process Development team as a Senior Scientist to support with our ongoing vaccine manufacturing.
- Lead delivery of key tasks within the technical transfer and implementation programme for new IMP products into manufacture, including training and supervision in GMP production activities. Also for scale up from clinical to commercial manufacture. Ensure process robustness, consistency and yield
- Lead delivery of key tasks within major development studies / projects, from concept to report. Consideration of risk and implementation strategy.
- Lead delivery of key support tasks, e.g. development and production of new cell or viral bank processes / technologies, or newly defined operator qualification activities.
- Support design & delivery of major process development / improvement projects, from conception to validation, with a view to increased process robustness, yield & success rate or reduced COGs to agreed timeframe.
- Line management of department team members as required
- Support preparation and delivery of production related tasks for commercialisation of IMP products, providing technical guidance to site
- Key supervisor/operator and trainer for equipment and processes involved in GMP manufacture of viral vaccine product for clinical trial and process validation purposes.
- Prepare Development Proposals, Plans and Reports, with identified costing, resources, and agreed milestones for delivery. Communicate plans effectively, with cross-functional consideration of site deliverables. Assist in troubleshooting and contribute to key technical investigations / assessments where required, to support on time delivery of Quality Investigations
- Support regulatory submissions by contributing to provision of technical reports and/or data
- Deliver assigned aspects of the Quality Management System and documentation to agreed timeframe. Escalate deviations in compliance to the Head of Department.
- Participate in continuous process improvement and provide support to key site projects and business deliverables
- Ensure training standards are maintained, as required in the role.
- Actively contribute to the development and maintenance of and enthusiastic, supportive and collaborative environment within the team, across the site and between sites.
- To deputise for the Process Development Principal Scientists, Deputy/Head of Department and team colleagues as required, and ensure owned tasks are assigned deputies in their absence
- Shift work and out of hours work as required
- To undertake any other duties as requested by the line manager in accordance with company requirements
- Degree qualification in biological sciences or related discipline, or equivalent experience
- Significant experience gained from several years within the Vaccine or Biologics Health Science sector or similar, in Process Development, Manufacture or Analytical functions
- Several years experience of Biological process / assay development, scale up and optimisation
- Cell culture experience/downstream processing/analytical techniques. Viral products beneficial
- Proven ability to lead and deliver significant programmes of work
- Strong experience/understanding of working in a GXP environment
- Good experience/understanding in New Product Introduction / technology transfer for GXP Production
- Excellent Scientific understanding of vaccines or protein chemistry through development, manufacture or analytics
- Self-motivated, able to deliver to tight deadlines and pressure
- Excellent communication and team management
- Flexibility in dealing with challenging and rapidly changing priorities and workloads
- Demonstrated creative & analytical thinking / problem solving skills
- Consideration of impact and application of change on people, process and systems
- Good organisational skills
- Team player with awareness of impact on people, process and systems