Our client, a leading global biopharmaceutical company dedicated to supporting customers and their businesses in ever better ways, this organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices, and a range of services. Selling in over 100+ countries with over 10,000 employees, they are one of the largest healthcare organisations in their defined sector. They are currently looking for an Upstream Senior Manager to join their biologics site. This role is within the Manufacturing Department and will be responsible for leading all upstream processing activities within the Manufacturing Team.
Build, lead and develop a team, with expertise specifically in the area of upstream cell culture processes using disposable technologies, to execute routine manufacturing activities.
Build schedule and resource plan to deliver manufacturing strategy.
Supervise daily upstream manufacturing activities and ensure production timelines are met, and GMP compliance is maintained.
Scale-up and validate steps in the upstream process.
Maintain Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture.
Ensure that the qualification and maintenance of equipment is up to date.
Provide expert input into process validation programmes, including cell bank production and process risk assessment.
Collaborate with QC and QA groups to ensure GMP compliance, manage deviation investigations and CAPA implementation, and support client auditing and agency inspections.
Participate in Quality and Safety regulatory audits.
BSc, MSC, PhD in a relevant discipline (e.g. Biochemistry, Chemistry, Process Engineering) or equivalent experience.
At least 5 years' relevant experience in bioprocess development and/or manufacturing, specifically on large scale mammalian cell culture/bioreactor systems.
Strong leadership competencies with demonstrated management skills.
Experience in dealing with FDA/HPRA and have a solid understanding of quality systems in terms of deviations, investigations, CAPA's and change controls.
To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 1 6321835 for a confidential discussion.