The opportunity
The MS&T External Manufacturing Director and Functional Head is a senior leadership role at Teva EMSO APAC and will be responsible for leading technical and manufacturing operation related engagements with external manufacturing partners (e.g., contract manufacturing organizations or CMOs). The Role will lead a team of professionals driving product robustness, ensuring seamless transfer, scale-up, and commercialization of products manufactured externally, supporting root cause investigations, providing technical intelligence to deviations, technical complaints, OOS & CAPAs, while ensuring manufacturing processes adhere to highest quality standards, compliance with regulatory requirement. Thus, the role will provide stewardship by ensuring that both manufacturing operations at external suppliers and performance of Teva products are monitored & maintained in a validated state. The ideal candidate will have a strong technical background in manufacturing sciences, process optimization, and a thorough understanding of Good Manufacturing Practices (cGMP), Project Management and will be adept at managing cross-functional teams to drive successful outcomes with external partners
How you’ll spend your day
Establish and Maintain Relationships with CMO/ CDMO manufacturing organization:
Develop and maintain strong, collaborative relationships with CMO/ CDMO manufacturing organization to ensure successful product manufacturing, process development, and scale-up activities
Provide technical expertise and guidance to CMOs on process optimization, scale-up, and troubleshooting.
Support transfer of new products or processes to external manufacturing sites
Monitor Performance
Assess the performance of external manufacturing partners, identify opportunities for improvement
Ongoing performance tracking for external manufacturing, including quality, cost, delivery, and efficiency. Ensure the alignment of external sites with Teva expectations
Communication and Escalation:
Serve as the primary point of contact for day-to-day technical and operational issues related to external manufacturing. Escalate concerns to senior management when necessary.
Manufacturing Support:
Oversee technical aspects of manufacturing processes to ensure they meet product specifications, regulatory standards, and Teva requirements
Optimize existing manufacturing processes for efficiency, robustness, and yield
Provide technical leadership in scale-up and transfer of new products from development to commercial manufacturing.
Process Improvement:
Continuously review and improve processes at external manufacturing sites to meet the Teva standards for product quality and operational efficiency
Introduce process improvements and ensure effective implementation at external sites
Evaluate and implement changes to improve robustness and scalability of manufacturing processes
Troubleshooting:
Provide technical troubleshooting support for issues that arise at external manufacturing facilities. Lead cross-functional teams to address /resolve issues that impact production timelines
Lead investigations into deviations and work with CMOs to implement corrective actions
Ensure Compliance:
Ensure that all manufacturing activities at external sites are compliant with cGMP, ICH, FDA, EMA, and other applicable regulatory requirements.
Audit and Inspection Support:
Lead and/or support external manufacturing site audits, inspections, and regulatory submissions, ensuring that CMOs meet all quality standards and regulatory requirements.
Deviation and CAPA Management:
Lead root cause analysis and corrective actions for manufacturing deviations, non-conformances, and other quality issues at external sites
Collaborate with external partners to implement CAPAs effectively
