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R&D Manager
2 mesi fa
Eusa Pharma is seeking an experienced R&D Manager to lead our Analytical team in the development and validation of analytical methods, method transfer, and ICH stability studies for various stages of drug development.
Key Responsibilities- Develop and Implement Analytical Strategies: Define the analytical strategy for new and ongoing projects to ensure effective and efficient delivery of project work on time, according to project schedule.
- Ensure Compliance and Quality: Prepare, review, and approve protocols, reports, and other associated project/GMP documentation to ensure compliance with internal and country-specific regulations.
- Manage Team Resources: Manage internal team resources/schedules to ensure adequate planning and resource allocation for assigned development projects.
- Identify and Implement Solutions: Identify technical problems/issues and develop solutions, implementing them in agreement with Group Leader, Departmental Manager where appropriate.
- Manage External Partnerships: Manage, supervise, and approve any analytical activities outsourced to external labs or Contract Development and Manufacturing Organization.
- Ensure Laboratory Safety and Compliance: Ensure the R&D Analytical Laboratory is operated in a safe manner with full compliance to Standard Operating Procedures.
- Investigate and Resolve Issues: Take full responsibility for OOS/OOT/OOE investigations, ensuring thorough and timely investigations in accordance with procedures.
- Support Audits and Regulatory Activities: Provide support to QA department during Audits (internal/external) and promptly complete all assigned actions from audits.
- Collaborate with Regulatory Department: Provide support (as required) to Regulatory department to respond to deficiency letters and prepare relevant documentation for dossier variation submission or scientific advice documentation preparation.
- Participate in Team Projects: Actively participate in assigned Team Projects as Analytical SME.
- Due Diligence and Budgeting: Act as Due Diligence Advisor for CMC Module as required and prepare budget and review forecasts for analytical labs.
- Proven Track Record: +8 years proven track record in analytical team/laboratory management, including experience in analytical development and validation.
- Experience and Knowledge: Experience and knowledge in ICH guidelines, stability data management, and cGMP.
- Technical Competencies: Knowledge of analytical statistics tools and applications, perform trend analysis and evaluation.
- Analytical Techniques: Experience with analytical techniques for small molecules, including UPLC/HPLC, GC, KF, UV/Vis, and IR.
- Regulatory Knowledge: Knowledge of CMC regulation, with proven track record of deficiency letters management (analytical activities).
- Leadership and Collaboration: Leadership skills and strategic problem-solving ability; ability to successfully participate within extended, global multinational project teams and handle multiple challenges under pressure.
- Language Skills: Fluent English both spoken and written.
