Director Drug Product External Manufacturing

Director Drug Product External Manufacturing

Regeneron

Limerick, Ireland

Position Summary

The Director of Drug Product External Manufacturing is accountable for clinical and commercial drug product manufacturing operations at selected Contract Manufacturing Organizations and strategic partners throughout Europe. This is a leadership role with the primary focus of developing an external manufacturing network to support future growth of clinical and commercial products, establishing operations that are efficient and flexible, implementing continuous improvement practices and ensuring manufacturing processes deliver high quality medicines to our patients every time. The Director will lead multiple DP Manufacturing Teams located in Raheen and Dublin, lead key Joint Operational Steering Commmittees and serve as a key member of the Drug Product Manufacturing Leadership Team. The role reports directly to the Executive Director of Drug Product Manufacturing.

Essential duties and Responsibilities include, but are not limited to, the following:

  • Oversee all aspects of clinical and commercial parenteral drug product filling, labeling and packaging operations at CMOs within Europe;
  • Build, lead and manager a high performing team by hiring and developing skilled talent in all aspects of drug product manufacturing;
  • Lead and continually improve manufacturing partnership governance processes, define key meetings and agendas, establish efficient issue escalation and resolution processes, oversee manufacturing partner execution and performance, implement core and custom KPIs that enable proactive action to emerging issues in manufacturing and supply;
  • Ensure DP Manufacturing Teams (DPMTs) are sufficiently staffed and trained for rapid response to manufacturing events, proactively identify issues, effectively determine root cause, and implement effective CAPAs;
  • Support and collaborate with the Drug Product Project Management and Quality Assurance organizations to ensure successful technical transfers, process validations and CapEx project executions within your manufacturing partnership network of responsibility;
  • Collaborate with internal stakeholders to develop and deliver upon a strategic DP Manufacturing management framework including risk analysis, COGS, make vs buy evaluations, CapEx and product quality outcomes;
  • Ensure all external manufacturing operations are completed under cGMP conditions; ensures domestic and international regulatory compliance;
  • Support Procurement in contract and project plan negotiations;
  • Be knowledgeable of the CMO landscape and initiatives of strategic partners. Identify opportunities and risks that impact Regeneron’s commercial and clinical portfolios of medicines;
  • Support the preparation and review of manufacturing sections for BLA submission in relation to filling, packaging, and labeling as needed.

Knowledge, Skills and Capabilities

  • Demonstrated leader with expert knowledge of parenteral manufacturing, device assembly and finished label and package;
  • Excellent at building internal and external partnerships, efficient at identifying and removing barriers for team and projects, and effective at communicating to a wide audience of experience, skills and expertise;
  • Demonstrated technical expertise in drug product manufacture and/or product development;
  • Working knowledge of clean room or classified area requirements;
  • Deep process, equipment, automation, validation and technical knowledge;
  • Knowledge of transferring aseptic parenteral filling, device assembly and finish label & pack operations;
  • Highly skilled and experienced in collaborating with and influencing Contract Manufacturing Organizations and strategic partners;
  • Working knowledge of industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA, IMB, etc.);
  • Strong project management, interpersonal, cross- cultural, communication, negotiation and problem solving skills qualification preferable;
  • Six Sigma certification preferred;
  • Ability to travel 25% - 50%;
  • Fluent in English with a preference given to candidates with competencies in German, French and/or Spanish (oral and written);
  • A successful candidate will have the ability to think strategically while being able to quickly adapt to emerging situations. This individual must enjoy being challenged to think critically and embrace new and emerging technologies being developed within R&D.

Education and Experience:

  • Requires minimum BS/MS in a scientific discipline with 12+ years of related experience in a biopharmaceutical cGMP environment. MS/MBA preferred;
  • 5+ years in a management and/or leadership position required.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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