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For Employers

Director MS&T

Teva Pharmaceuticals

8 - 12 years

0 Lacs

maharashtra

Posted:3 weeks ago| Platform: Shine logo

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Skills Required

relationship management process optimization troubleshooting performance monitoring communication process improvement compliance deviation management technical expertise scaleup manufacturing support audit support capa management

Work Mode

On-site

Job Type

Full Time

Job Description

As a candidate for the position, your main responsibility will be to establish and maintain relationships with CMO/ CDMO manufacturing organizations. This includes developing and maintaining strong, collaborative relationships to ensure successful product manufacturing, process development, and scale-up activities. You will also provide technical expertise and guidance to CMOs on process optimization, scale-up, and troubleshooting. Supporting the transfer of new products or processes to external manufacturing sites will also be part of your role. Key Responsibilities: - Monitor the performance of external manufacturing partners and identify opportunities for improvement. - Track the ongoing performance of external manufacturing in terms of quality, cost, delivery, and efficiency. Ensure alignment with Teva's expectations. - Serve as the primary point of contact for day-to-day technical and operational issues related to external manufacturing. - Oversee the technical aspects of manufacturing processes to ensure compliance with product specifications, regulatory standards, and Teva requirements. - Optimize existing manufacturing processes for efficiency, robustness, and yield. - Provide technical leadership in the scale-up and transfer of new products from development to commercial manufacturing. - Continuously review and improve processes at external manufacturing sites to meet Teva's standards for product quality and operational efficiency. - Introduce process improvements and ensure their effective implementation at external sites. - Evaluate and implement changes to improve the robustness and scalability of manufacturing processes. - Provide technical troubleshooting support for issues that arise at external manufacturing facilities. - Lead investigations into deviations and work with CMOs to implement corrective actions. - Ensure that all manufacturing activities at external sites are compliant with cGMP, ICH, FDA, EMA, and other applicable regulatory requirements. - Lead and/or support external manufacturing site audits, inspections, and regulatory submissions to ensure CMOs meet all quality standards and regulatory requirements. - Lead root cause analysis and corrective actions for manufacturing deviations, non-conformances, and other quality issues at external sites. - Collaborate with external partners to effectively implement CAPAs. Qualifications Required: - Bachelor's degree in a relevant field such as Chemistry, Pharmacy, or Chemical Engineering. - Experience in pharmaceutical manufacturing, technical operations, or process development. - Knowledge of cGMP, ICH, FDA, and EMA regulations. - Strong communication and interpersonal skills to build relationships and effectively communicate with external partners. - Ability to troubleshoot technical issues and lead cross-functional teams to address and resolve production-related challenges. - Experience in auditing and inspecting manufacturing sites is preferred. - Strong problem-solving skills and the ability to implement process improvements effectively. (Note: No additional details of the company were mentioned in the job description),

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Teva Pharmaceuticals

Pharmaceutical Manufacturing

Tel-Aviv Petach Tikva

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Director MS&T