Senior Manager, MS&T External Manufacturing

Teva Pharmaceuticals Prikaži sve poslove

Zagreb
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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.The opportunityThe Senior 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 Validation
Providing technical intelligence to deviations, technical complaints, OOE, OOT, OOS & CAPAs, while ensuring manufacturing processes adhering to highest quality standards, compliance with regulatory requirements
Process improvements
Standards and new technology deployment
Following all applicable Global SOPs and Guidelines

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 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, 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 partnersHow 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

How We'll Take Care of YouAt Teva, better health starts from within, and that includes you. From day one, you'll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.When it comes to your career, you'll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you'll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.Already Working @TEVA?If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.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.

Teva Pharmaceuticals

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