דרושים Senior Director Global Ms & Sterile Biopharmaceutical Products ב-טבע ב-Ireland, Waterford

o Support process development, optimization, and scale-up of sterile and biologics manufacturing processes.o Implement process improvements, new technologies, and innovations in the sterile and biopharmaceutical production lines.

o Ensure manufacturing processes meet all regulatory requirements (FDA, EMA, ICH, GMP, etc.) and industry best practices.
o Conduct risk assessments for sterile and biologic product manufacturing and implement mitigation strategies.
o Support Preparation of technical reports and documentation to support regulatory filings and inspections.

o Lead the MS&T efforts in the launch and commercialization of new biologic and sterile products, ensuring smooth transitions from R&D to production at global manufacturing sites.
o Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Supply Chain, to ensure timely and compliant commercialization of products.
o Oversee the preparation and review of technical documentation, ensuring all regulatory and quality standards are met for launch
o Ensure that manufacturing processes are scalable and reproducible during commercialization, addressing any process challenges that may arise.
o Provide technical support for initial production runs, managing the scale-up process, troubleshooting, and process optimization to guarantee product quality and supply continuity.
o Support the development and implementation of launch strategies for global markets, working closely with regional teams to align manufacturing processes with market requirements.

o Lead continuous improvement initiatives and incorporate cutting-edge technologies to improve product quality, efficiency, and cost.
o Foster a culture of innovation within MS&T through the application of novel technologies and methodologies (e.g., automation, advanced analytics).

o Master’s or Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related field.
• Experience:
o Minimum of 10 years of experience in Manufacturing Science and Technology, with a strong focus on sterile products (injectables, biologics, etc.) in a GMP environment.
o Proven expertise in biopharmaceutical manufacturing processes such as cell culture, fermentation, purification, sterile fill-finish, and packaging.
o Extensive knowledge of sterile product technologies, including aseptic processing, validation, and cleanroom environments.

o Expertise in process design, process validation, and process optimization.
o Familiarity with modern technologies such as single-use systems, automation, and continuous processing.
o Advanced understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH, GMP).

o Ability to work in a fast-paced, global environment with multiple stakeholders.
o Willingness to travel internationally as required. (30-40%)

o Experience with biologic product lifecycle management.
o Expertise in analytical techniques for biologics and sterile product testing.
o Prior experience in managing or overseeing technology transfers across global manufacturing sites.

VP, Head of TGO Manufacturing Technical Services Group

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