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60 Watson Pharama Jobs
Director , MS & T
Watson Pharama
posted 5d ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
- 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.)
Employment Type: Full Time, Permanent
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based on 8 employees
Strict timing
Monday to Friday
Within city
Day Shift
Watson Pharama Benefits
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