Elusav Recruitment have a great opportunity for an Senior Manager - Upstream Drug Substance with a Dynamic Global Biopharmaceutical Organisation based in Cork.The successful candidate will have end to end Ownership of the Cell Culture processes and all operational related performance indicators. The position will also have direct leadership responsibilities over the cell culture function and co-leadership of the Drug Substance flow team/business unit in a matrix team as part of the site operating model. Organisation looking for a strong technical people leader, to both drive and develop team.Opportunity to join a highly reputable organisation, with extensive internal progression opportunities, as site continues to undergo expansion. Organisation are also currently experience strong product performance, and continue to invest heavily in the Irish operations. Hybrid working, and open on arrangement. Permanent opportunity with strong remuneration package. Full time onsite role.Responsibilities:Delivery of production plan for Drug Substance Manufacturing through the AOP & LRP timeframe.Ownership of the Cell Culture processes end to end and all operational related performance indicators.Lead and develop the Cell Culture team and broader Drug Substance team through active development planning, succession planning & talent mapping.Financial control of all operational expenses related to Drug Substance manufacturing including yearly & long-range planning budget management with quarterly forecasting, scrap management and variance management for standard costing.Responsibility for all Safety metrics, improvement plans and risk analysis for the Drug Substance area.Responsibility for all Quality metrics, Deviation management, CAPAs and change controls for the Cell Culture & broader Drug Substance manufacturing area.Strong technical understanding of biologics manufacturing (cell culture and/or purification).Active leader in operational safety & championing behavioural based safety.Strong focus on compliance, cost awareness, lean manufacturing.Responsible for the tiered daily management systems & daily management of operations to service the next stage of operations.Continuous improvement champion with proven delivery of numerous initiatives that have reduced costs, increased safety & compliance.Experience in tech transfer of new products to commercial facility (at scale or scale up).Requirements:Bachelor’s degree in biotechnology, chemical or biochemical engineering, biochemistry or biosystems engineering, or related field or equivalent experience is preferred.Leadership experience within the GMP Biologics Drug Substance operational environment with strong demonstration of Decision Making, Influence & Collaboration, Agility and Leadership at the appropriate Level.Past experience and demonstrated ability to successfully influence team performance in a high-performance team is strongly preferred.Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.Experience with regulatory inspections and direct interaction with regulatory inspectors.Demonstrated management of resources, schedule and equipment is strongly preferred.Track record of embedding a strong Quality culture. QMS experience preferred.Highly developed organisational and leadership skills.Process development and/or technology transfer experience preferred.Contact:If you would like to learn more about the vacancy, apply now, or contact Brendan Mullins at Bmullins@elusav.com or +353 61 527 150.
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