Manufacturing Science & Technology Site Lead (m/f/x)
For our Process Engineering department, we are looking for a
R-240291
Fulltime / fixed-term 2 years/ non-tariff
The Manufacturing Science & Technology (MS&T) Site Lead is accountable to define strategy and provide technical direction and leadership in support of the Site’s Manufacturing Value Streams (Base Fractionation, Bulk, Aseptic Filling, Visual Inspection) with direct impact on safety, quality, reliability of supply across the diverse range of complex processes and products.
This role leads a team of engineers and scientists with expertise in cell culture, purification, formulation, vial and syringe aseptic filling, and packaging manufacturing activities for liquid and lyophilized parenteral products.
The Opportunity
- Provides single point of technical contact for the Site’s Manufacturing Operations across each Value Stream and Facility
- Develops and maintains diverse collaborative network to enable comprehensive ongoing technical support of manufacturing issues and improvements
- Partners with global Centers of Excellence, Process Owners, and Product Technical Stewards to improve network Process Robustness through process monitoring, “Quality by Design” (QbD) life cycle management, and global process/technology design standardization
- Provides technical design leadership, risk management, implementation, and effectiveness check of changes
- Provides deviation technical assessment, justification, investigation, and determination of corrective and preventive actions (CAPAs)
- Provides technical leadership of site and global Taskforces to resolve business critical and/or complex deviations and issues
- Understands the true regulatory requirements and partners with Manufacturing Value Streams, Quality and Regulatory Affairs to proactively develop more efficient ways to meet these requirements
- Lead technical aspects of site regulatory submissions, inspection readiness, execution, and finding responses
- Steers internal/external debate and discussions at high levels and guides constituents towards consensus around strategic/policy making topics
Your Skills and Experience
- Undergraduate/graduate degree in Engineering or related technical field
- 10+ years working in Process Engineering or commercialization of biopharmaceutical products and processes in Pharmaceutical, Chemical Manufacturing or similar industry.
- Demonstrated experience in process monitoring, analytics, and improvement development & execution.
- Strong communication, negotiation, and conflict management skills to influence technical experts and stakeholders including non-specialists, at all levels in the organization.
- Demonstrated experience in managing, organizing, developing, and deploying best practice frameworks, processes, tools, and templates.
- 5+ years of experience managing and working within a global matrix organization.
- Involvement in cross-functional, multicultural, and international teams.
- Must have a strong understanding of biopharmaceutical operations and relevant GMP regulations and regulatory guidance
What we offer
- Excellent income potential and extended benefits
- Two additional leave days for your personal wellbeing
- Family services such as psychological support, legal advice, family care services and more for you and your direct family
- Hybrid working models
For more information, please check out our global benefits below
We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.
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CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring.
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