The Role
We are seeking a Senior Director to lead our Global MS&T team in the development and optimization of sterile and biopharmaceutical manufacturing processes. This individual will provide advanced technical expertise and collaborate with cross-functional teams to ensure compliance, efficiency, and high-quality products.
Responsibilities
1. Process Optimization
Support process development, scale-up, and implementation of sterile and biologic manufacturing processes, ensuring performance, scalability, and quality standards are met.
2. Regulatory Compliance
Ensure all regulatory requirements (FDA, EMA, ICH, GMP) are met for manufacturing processes, conducting risk assessments and implementing mitigation strategies.
3. Technology Transfer
Oversee the technical transfer of manufacturing processes from R&D to commercial scale, supporting technology transfer between internal and external sites.
4. Launches and Commercialization
Lead the MS&T efforts in launching and commercializing new biologic and sterile products, ensuring smooth transitions from R&D to production at global manufacturing sites.
5. Collaboration and Stakeholder Engagement
Work cross-functionally with R&D, Quality Assurance, Supply Chain, and Operations teams to deliver biologics and sterile products.
6. Training and Knowledge Sharing
Provide training and guidance to junior team members and site operations teams on sterile and biologic product manufacturing.
7. Continuous Improvement and Innovation
Lead continuous improvement initiatives, incorporating cutting-edge technologies to improve product quality, efficiency, and cost.
Requirements
1. Education:
Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related field.
2. Experience:
Minimum of 10 years in Manufacturing Science and Technology, with a focus on sterile products (injectables, biologics, etc.) in a GMP environment.
3. Technical Skills:
Expertise in process design, validation, and optimization, familiarity with modern technologies like single-use systems and automation.
4. Leadership:
Proven ability to lead cross-functional teams, strong communication and presentation skills.
5. Other:
Ability to work in a fast-paced, global environment, willingness to travel internationally as required.
Preferred Qualifications:
Experience with biologic product lifecycle management, analytical techniques for biologics and sterile product testing, and managing technology transfers across global sites.