Senior Director Global Ms & Sterile Biopharmaceutical Products jobs at Teva in Ireland, Waterford
Teva Senior Director Global MS & Sterile Biopharmaceutical Produc... Ireland, Waterford
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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.
Reports To
VP, Head of TGO Manufacturing Technical Services Group
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
These jobs might be a good fit
Share
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.
Reports To
VP, Head of TGO Manufacturing Technical Services Group
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
These jobs might be a good fit
