Teva Director MS & - External Manufacturing Supply Operations 

Malaysia, Penang, George Town 

290510990

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

Technology Transfer and Scale-up:

• Manage Technology Transfer
• Lead the technology transfer process for new products or processes to external manufacturing sites, ensuring that the transfer is executed smoothly and within timelines

Manage Material transfer projects:

• Lead material transfer project s (Changes in API/ Excipient etc.) and ensure timely completion

Scale-up Support:

• Oversee the scaling up of manufacturing processes, ensuring that commercial production is consistent with development batches in terms of product quality and process performance.

Cross-departmental Coordination:

• Work closely with internal teams such as Quality Control, Regulatory Affairs, Supply Chain, and Product Development to ensure seamless integration of manufacturing processes and that timelines are met.

Project Management:

• Manage or contribute to cross-functional project teams, ensuring that all aspects of product commercialization and manufacturing at external sites are executed efficiently and on schedule

Reporting & Documentation:

• Prepare technical reports, presentations, and documentation for both internal and external stakeholders.
• Monitor and report on key performance indicators (KPIs) for external manufacturing operations, providing updates to senior leadership.

• Master’s Degree in Pharma, Science, Chemistry, or Chemical Engineering
• Ph.D, in Pharmaceutics is preferred
• 20+ years pharmaceutical manufacturing/validation/other related experience for US FDA approved sites
• Strong experience in working with external manufacturing partners (CMOs, CDMOs, etc.)
  

Regional Head, EMSO APAC

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.