This role represents a superb opportunity to join a start-up biotech facility with a superb, progressive company culture based in the Midlands. Previous experience with Mammalian-based cell culture is essential in this instance.
• Build, lead and develop a team with expertise in biopharmaceutical process development, specifically in the area of upstream cell culture processes using disposable technologies
• Develop, optimise, scale-up and validate all steps in the upstream process
• Work with external service providers to ensure delivery of projects related to the upstream process
• Manage technical transfer of processes into the GMP production facility
• Establish Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture
• Work closely with analytical development activities to support process development and process characterisation studies
• Provide expert input into process validation programme, including, cell bank production and characterisation, cleaning validation, leachable studies
• Manage production, supply and qualification of cell culture media and components
• Provide support for other processing activities including purification and buffer preparation.
• Support writing of relevant sections of CTD to support regulatory submissions
• Participate in Quality and Safety regulatory audits
• Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices
Qualification and Experience:
• BSc, MSC, PhD in a relevant discipline (e.g biochemistry, chemistry, process engineering) or equivalent experience.
• At least 3-7 years relevant experience in bioprocess development and/or manufacturing, specifically on cell culture / bioreactor systems.
• 2-5 year’s management or supervisory experience in a bioprocess development and/or manufacturing environment.
• Cell culture, lab-scale and pilot scale bioreactor experience
• Knowledge of protein purification methods would be an advantage
• Use of disposable technologies and leachable studies
• Process characterisation and process validation experience
• Cell bank safety testing
• Good knowledge of regulatory guidelines relating to process development and manufacture including QbD and Risk Management
• Ability to write relevant sections of CTD for regulatory submission
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747