Assoc Dir MS&T

We Are Teva

Our Team, Your Impact

• The Associate Director, MS&T External Manufacturing is a senior individual‑contributor leadership role within Teva Global ExM, responsible for driving all technical and manufacturing‑operations engagements with external partners, including Contract Manufacturing Organizations (CMOs). The role provides strategic and hands‑on oversight to ensure product robustness, seamless technology transfer, scale‑up, and successful commercialization of externally manufactured products.
• This position leads a team of technical professionals in supporting complex root‑cause investigations, offering technical intelligence for deviations, technical complaints, OOS results, and CAPA activities. The Associate Director ensures that all external manufacturing processes consistently meet the highest standards of quality, operational excellence, and cGMP compliance, while maintaining products and processes in a validated state throughout their lifecycle.
• 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, IR or MR OSD products OR simple or complex injectables OR topical products experience and will be adept at managing cross-functional teams to drive successful outcomes with external partners

How You’ll Spend Your Day

1. External Manufacturing Partner Management:

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
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.

2. Process Development & Optimization:

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.
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

3. Quality and Regulatory Compliance:

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

4. 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.

5. Cross-functional Collaboration:

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

6. 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 Skills and Experience

• 20+ years pharmaceutical manufacturing/validation/other related experience for US FDA approved sites
• Master’s Degree in Pharma, Science, Chemistry, or Chemical Engineering 
• Strong experience in working with external manufacturing partners (CMOs, CDMOs, etc.)
• Strong technical background with expertise in manufacturing processes, process development, and scale-up.
• Excellent problem-solving, troubleshooting & analytical skills.
• Ability to communicate complex technical concepts clearly to both technical and non-technical stakeholders.
• Strong project management skills, with the ability to manage multiple projects simultaneously.
• Ability to work collaboratively in a team environment and build relationships with external partners.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with manufacturing management systems (e.g., SAP, MES).

Salary Range

How We’ll Take Care of You

Teva’s Equal Employment Opportunity Commitment