Work as MS&T Director at Teva | Ph.D, M.Pharm, MSc Apply

Teva Is a global pharmaceutical leader and the world's largest generic medicines producer, committed to Improving health and Increasing access to quality health solutions worldwide.

Post : Director, MS&T - External Manufacturing & Supply Operations

Job Description
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

Long Description
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.

Candidate Profile
• 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.)

Additional Information
Experience : 20+ years
Qualification : Ph.D, M.Pharm, M.Sc
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : External Manufacturing & Supply Operations
End Date : 28th February 2025