A market leading Gene and Cellular Therapy Company is experiencing a period of rapid growth and expansion and as such, is seeking 4 Process Development Scientists/Engineers to join their award winning company. As a Process Development Scientist/Engineer, the purpose of this role is to provide technical and scientific support to the clinical and commercial manufacturing activities, including technology transfer, process validation, technical troubleshooting, complex deviation investigations, change control, and continuous improvement.
Process Development Scientist/Engineer Key Responsibilities:
- Provide technical expertise to other departments and contribute to the scientific and business needs of the company through the application of fermentation and bioprocessing.
- Provide leadership and direction on project activities to the various in-house and partnered project teams to ensure all project deliverables and milestones are met within agreed scope, timelines and budget.
- Prepare internal documentation to ensure quality and compliance required for regulatory submissions.
- Technical reviewer of manufacturing documentation (batch manufacturing records, deviation handling, CAPA, change controls, SOPs, etc.).
- Generate and review documentation supporting technology transfer and NPI. Define success criteria for technical transfer and provide expert evaluation of the technical outcomes.
- Actively provide solutions to process problems and contribute to company-wide issues where required.
- Have relevant experience in process development/validation and working in a GMP environment. Preferably upstream adherent/suspension cell culture and downstream (purification) processing and/or aseptic processing/fill & finish.
- Possess expertise in the use/application of variety of problem solving tools and quality risk assessment methodologies.
- Have experience managing multiple different projects, whilst demonstrating excellent organisational and time management skills.
- Be familiar with statistical analysis platforms such as Minitab.
- Possess a Bachelor’s degree minimum in a relevant life science/engineering discipline. Masters and PhD/EngD preferred.
For more information on rates and applying, please contact Charles on 0161 942 7163.