Senior Manager, MS&T External Manufacturing

Senior Manager, MS&T External Manufacturing

Teva

Zagreb, Croatia

How you’ll spend your day

• Establish and Maintain 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;
• 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;
• 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;
• 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;
• 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;
• 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 that all manufacturing activities at external sites are compliant with cGMP, ICH, FDA, EMA, and other applicable regulatory requirements;
• Knowledge of Veeva/GRIDS and Harmony TW systems and/or other Regulatory/Quality DMS & reviewing regulatory documentation;
• Support and/or support external manufacturing site audits, inspections, and regulatory submissions, ensuring that 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 implement CAPAs effectively;
• Lead multiple products technology transfer activities for IR or MR OSD products OR simple or complex injectables OR topical products;
• Support the technology transfer process for new products or processes to external manufacturing sites, ensuring that the transfer is executed smoothly and within timelines;
• Support material transfer projects (Changes in API/Excipient etc.) and ensure timely completion;
• Oversee the scaling up of manufacturing processes, ensuring that commercial production is consistent with development batches in terms of product quality and process performance;
• 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;
• 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;
• 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;
• 8-12 years pharmaceutical manufacturing/validation/other related experience for US FDA approved sites;
• Strong experience in working with external manufacturing partners (CMOs, CDMOs, etc.);
• Good oral and written communication skills, attention to detail, ability to work independently, good people skills, demonstrated organizational skills;
• Strong technical background with expertise in pFMEA, manufacturing processes, process development, and scale-up, OpEx, Lean Six-Sigma;
• Excellent risk assessment, root-cause analysis, 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);
• Thorough familiarity with cGMPs, SOP's, relevant government regulations, and current industry standards;
• Experience in Solid Oral, Semisolid and Injectable Products Manufacturing and Technologies in Pharma Industry.