Senior Manager - Characterization R&D - Extractables & Leachables

Our client is an American multinational healthcare company. For over a century now, they have delivered on their commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world. At the intersection of progress and purpose, they are redefining what it means to be a global medtech leader. Their forward-looking leadership team is a driving force in ensuring we meet the needs of all our stakeholders—every day and everywhere. They strive to create lasting value by empowering their patients, protecting the planet, and championing people and communities.

Responsibilities:

• Sr. Manager, R&D characterization is responsible for contributing to all phases of Extractable & Leachable studies carried out IH and at CROs. This would include study design as sample preparation, analysis, and data interpretation.
• Independently or with support of sub department manager, author and contribute to the experimental protocols, process and interpret data, author technical reports in English.
• Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need.
• Ensure compliance in all research, data collection and reporting activities.
• Supervise and direct the lab work for junior level executives.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Support the build out of the R&D- E&L laboratory.
• Develop and enhance technical capability through training and on job experience.
• Ensure laboratory is equipped with instrumentation that is qualified to appropriate standards, maintained in a functional state and aligns with the business needs.
• Key contributor during experimental study designs, execution and review/approval at IH & CROs study.
• Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience
• Collaborate with a multidisciplinary team of subject matter experts to generate innovative solutions to complex problems through the use of multiple disciplines and technical principles.
• Create innovative products/processes/methods through novel combinations of expertise within the organization.
• Contribute to the long-term scientific strategy of the department.
• Influence the regional external regulatory environment in the areas of Extractables & Leachables,
• Elemental Impurities, and Structure Elucidation.
• Write technical reports and documenting development work.

Requirements:

• 15+ years of experience in Extractables & Leachables R&D.
• The candidate needs to have strong exposure in dealing with complex E&L Case studies.
• Should have experience managing and leading teams.
• Should hold a PhD, Masters or equivalent with strong exposure to the chemistry side of pharmaceuticals.