Sr. Manager- ExM MS&T- On-Site

Teva; Maharashtra; On-site; INR 3,500,000 - 5,500,000; Full time

Benefits offered by this job

Medical insurance

Wellbeing programs

Job summary

Teva India in Vishakhapatnam, Andhra Pradesh, seeks a Sr. Manager MS&T External Manufacturing to lead technical engagements with CMOs to ensure product quality and on-time delivery. The role requires deep GMP knowledge, sterile/injectables experience, and cross-functional collaboration.

You will drive technology transfer, scale-up, and CAPA investigations, while monitoring performance, ensuring regulatory compliance, and supporting audits across global sites.

Qualifications

• Must-have advanced degree in pharma/science/chemistry or chemical engineering.
• Strong GMP knowledge with experience in sterile/injectable manufacturing.
• Experience leading tech transfer, scale-up and CAPA investigations.

Responsibilities

• External Manufacturing Partner Management: establish relationships with CMOs/CDMOs and guide process optimization, scale-up and troubleshooting.
• Monitor performance and ensure alignment with Teva expectations across QA/QC, delivery and cost.
• Technical development, scale-up, and technology transfer for new/existing products.
• Quality & Regulatory Compliance: support audits, deviation investigations, CAPA implementation, and regulatory submissions.

Skills

Sterile / Injectable manufacturing

Technology transfer

Scale-up

Deviations & CAPA management

Process development

Lean Six-Sigma

Project management

cGMP compliance

Education

Master’s Degree in Pharma, Science, Chemistry, or Chemical Engineering

Tools

Veeva/GRIDS

Harmony TW

Job description

We Are TevaWe’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.Our Team, Your ImpactThe Sr. Manager MS&T External Manufacturing as individual contributor role at Teva Global ExM 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 provide:Technical support for External Pharmaceutical Manufacturing Network to ensure operational excellence, product quality, and optimal product flow to respective markets.Works with the regional/global commercial sites to facilitate new and in-line technology transfer and commercialization projects.Scale up, Technology transfer and ValidationProviding technical intelligence to deviations, technical complaints, OOE, OOT, OOS & CAPAs, while ensuring manufacturing processes adhering to highest quality standards, compliance with regulatory requirementsProcess improvementsStandards and new technology deploymentFollowing all applicable Global SOPs and GuidelinesThus, 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 stateThe ideal candidate will have a strong technical background in manufacturing sciences, process optimization, and a thorough understanding of Good Manufacturing Practices (cGMP), Project Management, simple & complex Sterile/injectables products experience and will be adept at managing cross-functional teams to drive successful outcomes with external partnersHow You’ll Spend Your DayExternal Manufacturing Partner Management:• Establish and Maintain Relationships with CMO/ CDMO manufacturing organization:o Develop and maintain strong, collaborative relationships with CMO/ CDMO manufacturing organization to ensure successful product manufacturing, process development, and scale-up activitieso Provide technical expertise and guidance to CMOs on process optimization, scale-up, and troubleshooting.o Support transfer of new products or processes to external manufacturing sites• Monitor Performance:o Assess the performance of external manufacturing partners, identify opportunities for improvemento Ongoing performance tracking for external manufacturing, including quality, cost, delivery, and efficiency. Ensure the alignment of external sites with Teva expectations• Communication and Escalation:o 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.Process Development & Optimization:• Manufacturing Support:o Oversee technical aspects of manufacturing processes to ensure they meet product specifications, regulatory standards, and Teva requirementso Optimize existing manufacturing processes for efficiency, robustness, and yieldo Provide technical leadership in scale-up and transfer of new products from development to commercial manufacturing.• Process Improvement:o Continuously review and improve processes at external manufacturing sites to meet the Teva standards for product quality and operational efficiencyo Introduce process improvements and ensure effective implementation at external siteso Evaluate and implement changes to improve robustness and scalability of manufacturing processes• Troubleshooting:o Provide technical troubleshooting support for issues that arise at external manufacturing facilities. Lead cross-functional teams to address /resolve issues that impact production timelineso Lead investigations into deviations and work with CMOs to implement corrective actionsUnderstanding of statistical data analysisQuality and Regulatory Compliance:• Ensure Compliance:o Ensure that all manufacturing activities at external sites are compliant with cGMP, ICH, FDA, EMA, and other applicable regulatory requirements.o Knowledge of Veeva/GRIDS and Harmony TW systems and/or other Regulatory/Quality DMS & reviewing regulatory documentation• Audit and Inspection Support:o Support 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:o Lead root cause analysis and corrective actions for manufacturing deviations, non-conformances, and other quality issues at external siteso Collaborate with external partners to implement CAPAs effectivelyHow You’ll Spend Your DayTechnology Transfer and Scale-up:• Manage Technology Transfer:o Experience on due diligence process for site selection & technical gap assessment & actions implementationo Lead multiple products technology transfer activities for simple & complex injectables products.o Support 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:o Support material transfer projects (Changes in API/ Excipient etc.) and ensure timely completion• Scale-up Support:o 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-functional Collaboration:• Cross-departmental Coordination:o 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:o 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 scheduleReporting & 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 ExperienceMaster’s Degree in Pharma, Science, Chemistry, or Chemical Engineering8-12 years pharmaceutical manufacturing/validation/other related experience for US FDA approved sitesStrong experience in working with external manufacturing partners (CMOs, CDMOs, etc.)Needs to be experienced in Sterile / Injectable Products Manufacturing and Technologies in Pharma IndustryStrong technical background with expertise in pFMEA, manufacturing processes, process development, and scale-up, OpEx, Lean Six-SigmaThe role is on-site in Vishakhapatnam (Andhra Pradesh INDIA)Travel requirment- 20-30% local or InternationalHow We’ll Take Care of YouAt Teva India, care is at the heart of how we work. From your first day, you’ll be welcomed into a people-first culture built on inclusion, respect, and belonging.That support extends to you and your loved ones through benefits designed for real life. These include comprehensive medical insurance, OPD coverage, annual health checkups, term life and accident insurance, and confidential emotional wellbeing support through our Optum Employee Assistance Program. You’ll also enjoy healthy meals at work, holistic wellbeing initiatives, and volunteering programs that help you give back to the community.Your growth matters too. You’ll have opportunities to build future-ready skills, collaborate on projects with global teams, explore internal career opportunities, and learn through programs such as our AI-enabled Teva Twist program, R&D Academy, continuing education, and mentorship.Join our vibrant workplace, where we celebrate milestones, festivals, achievements, and community impact together.Teva’s Equal Employment Opportunity CommitmentTeva 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.