Manufacturing Sciences And Technology Senior Manager - Pharmaceutical Company Milano

Manufacturing Sciences And Technology Senior Manager - Pharmaceutical Company
Milano
Lombardia, Milano

Manufacturing Sciences and Technology Senior Manager - Pharmaceutical Company Chaberton Professionals, a division of Chaberton Partners dedicated to the research and selection of Middle Management profiles, is currently looking for a Manufacturing Sciences and Technology Senior Manager for a pharmaceutical Company. He/she will be responsible for: Ensuring Technology Transfer into manufacturing, leading all facets of Process and Continued Process Verification. Ensuring commercial products are maintained in their Validated Status in accordance with current good manufacturing processes (cGMP). Responsibilities Leads the process-related activities enabling Drug Substance and bulk Drug product (bulk DP) manufacturing. Facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities. Process Validation and Continued Process Verification activities. Offers molecule steward and drives process lifecycle management initiatives, eventually in accordance with customer's molecular strategy as needed. Supports manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements, and scientific expertise in the Drug Substance, Bulk DP field. Provides strong technical leadership to process engineers, R&D scientists, and Manufacturing, HSE, Engineering and QA associates for clinical and commercial production. Coordinates scientifically and/or technically based process improvements of clinical and commercial manufacturing processes. Requirements: M. S. /M. A. in Chemical or Pharmaceutical Engineering, or related field, with a minimum of 8/10 years of relevant experience. 10 years in a leadership role of sciences/technology groups in a fast-paced regulated production environment. Broad experience in all process areas and ancillary processes (CIP, SIP). Demonstrated experience with scale-up and optimization of lab procedures up to commercial scale under GMP conditions, including knowledge and application of Pharmaceutical Quality by Design (QbD) principles. J-18808-Ljbffr