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Biologics Virus Clearance Validation Leader
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Full-time
- The Biologics Virus Clearance Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
- Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:BSc in Scientific Discipline Minimum 5 years' demonstrated experience in the Pharmaceutical Industry in leading the technical aspects of the product lifecycle, including technical risk assessments, product control strategies, bench, pilot & commercial scale validation studies, QbD, PPQ, CPV and change control.
- Experience in program management, process validation, BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, change and deviation management), and knowledge management.
- GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive.
- While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive.
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