Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunity

We are seeking an experienced and dynamic professional to join our Global Manufacturing Science and Technology (MS&T) team. This role is focused on providing advanced technical expertise in the manufacturing processes for sterile and biologics products. The ideal candidate will have significant experience in the production and quality control of biologics and sterile pharmaceutical products, including the integration of technology, process optimization, and regulatory compliance at a global scale.

How you’ll spend your day

Process Optimization and scale-up
o    Support process development, optimization, and scale-up of sterile and biologics manufacturing processes.
o    Work collaboratively with internal teams to design robust manufacturing systems, ensuring they meet performance, scalability, and quality standards.
o    Implement process improvements, new technologies, and innovations in the sterile and biopharmaceutical production lines.

Regulatory Compliance and Risk Management
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.

Technology Transfer
o    Oversee the technical transfer of manufacturing processes from R&D to commercial scale.
o    Support technology transfer between internal and external manufacturing sites.
o    Develop and maintain best practices for the transfer of sterile and biologic processes to different global locations.

Launches and commercialization 
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.

Collaboration and Stakeholder Engagement
o    Work cross-functionally with R&D, Quality Assurance, Supply Chain, and Operations teams to ensure the seamless delivery of biologics and sterile products.
o    Provide technical leadership in troubleshooting and resolving manufacturing issues.
o    Support the global MS&T team in creating and executing strategies that ensure high-quality and reliable supply.

Training and Knowledge Sharing
o    Provide training and guidance to junior team members and site operations teams in the areas of sterile and biologic product manufacturing.
o    Act as a subject matter expert (SME) for sterile and biologic products across global manufacturing sites.
o    Promote the sharing of best practices and new innovations to foster continuous improvement across the organization.

Continuous Improvement and Innovation
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).

Your experience and qualifications

 Education:
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.

Technical Skills:
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).

Leadership:
o    Proven ability to lead cross-functional teams and collaborate with stakeholders at all levels.
o    Strong communication, presentation, and training skills, with the ability to convey complex technical information to diverse audiences.

Other:
o    Ability to work in a fast-paced, global environment with multiple stakeholders.
o    Willingness to travel internationally as required.

Preferred Qualifications:
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

Keren Wiess

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