NuVision is looking to recruit an exceptional and committed research and development, and production scientist, with skills in engineering and process validation. The successful applicant will join a small R&D team taking responsibility of the day-to-day research activities involved in development and validation of NuVision Tereo manufacture process. This position would suit a person who has experience in process validation and GMP production systems, and has worked with human tissue products. Specific activates will include:
- Validation and clinical implementation of NuVision’s new Automated laser Cutting and Quality Assessment (ACQA) system which involved high throughput automated laser cutting and quality assessment of human amniotic membrane-derived tissue products.
- Contributing to the design and implementation of continuous validation and optimisation of the Tereo manufacture process to ensure clinical product meet stringent internal and regulatory safety and quality standard requirements.
- Supporting the operational team in GMP manufacturing Tereo processed amniotic membrane-based clinical product, Omnigen.
Personal drive, commitment, organisational and business skills are key qualities required to deliver outstanding results within this rapidly growing area. The role will be based in the MediCity facilities and will report to the Chief Scientific Officer (CSO).
- Validation and qualification activities including MVPs, IQs, OQs, PQs, FATs and SATs for new and existing equipment, facilities and processes.
- Research planning and implementation for process and product continuous development and validation to enable improved production efficiencies.
- Perform wider R&D activities including processing and analysing results
- Ensure all key deadlines, milestones, budgets and resources assigned to specific tasks and outcomes are met
- Develop and maintain a formal project plan
- Manage multiple projects concurrently
- Assist operational team in the clinical manufacturing and quality assessment activities for Tereo processed amniotic membrane.
- Support internal quality and regulatory teams on ensure all documentation and risk assessments meet internal validation and qualification assurance criteria.
- Provide verbal and written communication and reports with stake holders at all levels
- Write, assist and support in new project proposals and grant applications
- Write and amend manufacturing, equipment, facility and quality SOPs
- Degree in engineering with knowledge on biological science. Postgraduate degree desirable.
- Experience in working within a multi-cultural and multi-disciplined environment to solve diverse and complex problems.
- Experience in production/process improvement and validations development.
- Experience working in a highly regulated industry, preferably in human tissue
- Knowledge and working application of HTA, ISO, GMP and EN regulations.
- Experience in leading and performing validation and qualification activities. Preferably in clean-room set-up and medical-grade capital purchases.
- Experience in overseeing equipment maintenance.
- Proficient user of Microsoft suite (Word, Excel, PowerPoint, Access) and knowledge of programming (VBA, C#)
- Able to build good working relationships within and between external and internal teams.
- Able to work autonomously and adaptable to manage changing priorities and timeframes.
- Interest or experience working in a start-up.
Professional proficiency in a major European language (French, Spanish, German), desirable.
To apply please email your cover letter and CV to firstname.lastname@example.org