Key Responsibilities include but are not limited to:

• Support all aspects of the manufacturing process from formulation and filling to visual inspection
• Technical review of change controls for impact to product quality and safety
• Provide on-floor technical support and troubleshooting
• Lead process improvement initiatives across all areas of manufacturing
• Report generation to support GMP manufacturing activities
• Collection, organisation, trending, and analysis of GMP manufacturing data
• Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process
• Develop objectives and ensure alignment with site goals
• Liaise with teams to identify the risks, gaps and closure plans
• Lead the pre-GMP line activities along with all associated protocols and reports
• Ensure information transfer to process engineering group for all cycle development activities
• Review sampling plans for all activities and ensure compliance with all technology transfer requirements
• Ensure appropriate scientific and engineering documentation is collated and approved for a robust Process Flow document

Requirements:

• An honours degree in Science/Biotechnology (or a related discipline)
• 5+ years’ experience in the following areas mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
• Significant exposure to sterile operations and/or Tech Transfer projects
• Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
• Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
• Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
• Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes.

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.