Job Description

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
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

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.

Your experience and qualifications

• 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.)

Reports To
Regional Head, EMSO APAC
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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.