Brendan Fish
Director of Biologics & RNA Centre of Excellence, CPI
• A trusted and approachable leader, with an ability to generate networks of relationships built upon confidence and respect. Ability to engage and influence, at all levels, on operational, tactical or strategic initiatives, seeing the bigger picture of potential considerations and outcomes.
• A respected subject matter expert with a multi-layered understanding of biopharma chemistry, manufacturing and controls from discovery through to launch.
• Highly experienced in technical aspects of introduction of new pharmaceutical products to commercial manufacturing as well as management of the technical wellbeing of existing launched products. This includes technology transfer and all aspects of GMP manufacture, filling, inspection, device assembly and packaging for sterile liquids and suspensions (including biologics), inhaled liquids, tablets, oral suspensions and dermatological creams and ointments.
• Significant regulatory and audit experience (including FDA and MHRA) including regulatory submissions, pre-approval inspections and responses to questions. Involved in multiple regulatory audits.
Other key experience and interests include:
• Bioprocessing: process development & optimisation, scale-up, GMP manufacturing, validation and analytical biochemistry.
• Product characterisation and comparability studies.
• Biopharmaceutical formulation and delivery.
• Quality Control testing, including bio-analytical testing, biological potency assays, quality systems, documentation and reporting.
• The design, construction and GMP operation of biopharmaceutical production facilities.
• Process simulation and cost modelling.
• Strategies for Production, QA, QC, Marketing, Operations, Regulatory Affairs and Engineering for all aspects of Bioprocess Development.
