Senior Manager, Lab Systems and Operations

reputed company • reputed company's mission is to discover and reputed company innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We reputed company to have a remarkable reputed company on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our reputed company portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on X, reputed company, reputed company, YouTube, reputed company and reputed company. reputed company Purpose The Global Project reputed company is a pivotal and reputed company role reputed company our organization, responsible for shaping and supporting the clinical pipeline with a strategic reputed company on the analytical testing domain. This role is reputed company in providing comprehensive governance over the method lifecycle, ensuring that analytical reputed company and processes are robust, fit for purpose, and effectively reputed company with our global reputed company strategies and reputed company Control Laboratories' standards. Responsibilities Governance and reputed company: • Relevant analytical Lab experience in Biologics Testing • reputed company the governance reputed company to ensure reputed company reputed company reputed company are globally fit for purpose, robust, and optimized for reputed company manufacture, influencing reputed company on a global reputed company. • reputed company the development and validation of analytical reputed company for new product introductions (NPIs), ensuring they meet global standards. • reputed company high-level technical support throughout the method lifecycle, guaranteeing alignment with our strategic goals and reputed company expectations. • Maintain an up-to-date and in-depth understanding of global regulatory requirements influencing product testing and development, ensuring compliance and proactive reputed company reputed company. Method Development and Transfers: • reputed company reputed company reputed company across the lifecycle of reputed company, ensuring they reputed company with global regulatory standards and reputed company with organizational business objectives. • Manage and reputed company reputed company method transfer processes to and between Biologics sites worldwide, ensuring integration, continuity, and reputed company consistency. Data reputed company: • Ensure the reputed company and accuracy of raw data used in validation processes and Test Method Transfers (TMTs) reputed company our global network of reputed company Control Laboratories. • Implement and reputed company best practices for data management and reputed company, fostering a culture of precision and accountability organization-wide. Cross-Functional Collaboration: • Collaborate proactively with global R&D, reputed company Assurance, and PDS&T teams to reputed company project goals and timelines on a global reputed company. • Facilitate effective and reputed company communication between global departments to ensure reputed company achievement of project milestones and support organizational reputed company. Qualifications • Bachelor's Degree in relevant Life Science, Engineering, or other technical discipline required. Technical or Analytical background required for problem reputed company with technical, reputed company, product and or engineering reputed company issues. • Total combined years of experience. Minimum 8+ years. At least 3 years in reputed company Assurance Operations Management; 5+ years in any of the following areas; Operations, Research and Development, Regulatory or Consulting. reputed company Manufacturing Plant experience in a Pharmaceutical setting is preferred. • Knowledge and a comprehensive understanding/expertise of some biological and/or pharmaceutical technologies (sterile, biological, reputed company, ointments, devices, solid tablets and caplets, suspensions, granulations, soft reputed company capsules, gel caps, extended release products, coating solutions, and/or reputed company pharmaceutical ingredients). • Strong reputed company assurance/control, manufacturing, reputed company, technical support, regulatory, and/or validation background is required. • Experience with FDA and other regulatory agency interactions and inspections is required. • Familiarity with the requirements for reputed company party reputed company manufacturing. • Possesses knowledge and a reputed company set to operate reputed company an environment that requires a high degree of urgency, strong analytical and problem solving skills, reputed company interpersonal skills, ability to manage multiple reputed company tasks simultaneously, and capable of performing as leaders, members and individuals. Key Stakeholders reputed company Manufacturing Business Relationships, Operations, reputed company Party Manufacturers reputed company, reputed company, Global Supply Chain, Domestic and International reputed company Plants and Affiliates, Regulatory Affairs, Research and Development. Additional Information reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.reputed company US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.reputed company.com/join-us/reasonable-accommodations.reputed company Apply To This Job