Ms&T Senior Manager, Spray Drying - Pharmaceutical Company Milano

Ms&T Senior Manager, Spray Drying - Pharmaceutical Company
Milano
Lombardia, Milano

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 VerificationEnsuring commercial products are maintained in their Validated Status in accordance with current good manufacturing processes (cGMP). ResponsibilitiesLeads 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 drive process lifecycle management initiative, eventually in accordance to 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 fieldProvides 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. Actively liaises with external customers and internal partners to facilitate execution of customer projects. Represent the company sites as a domain expert during external and internal regulatory compliance inspections. Support the authoring, reviewing and approving of regulatory applications for customers as well as support responses to regulatory agencies. Support building and responsibly manage operational budgets for the MSAT organization of the site. Support continuous improvements and establish best-in-class Industrialization and TT function capabilities by improving the enabling processes and systems. Works multi-functional with process development, manufacturing, quality assurance, quality control, supply chain, and facilities departments to effectively transfer, maintain and commercialize processes in the facility. Ensure that changes to existing processes or the introduction of new processes are carried out and documented, according to approved change control procedures and in compliance with cGMP requirements. Requirements:M. S. /M. A.

in Chemical or Pharmaceutical Engineering, or related field, with minimum of 10 years of relevant experience;8+ years in a leadership role of sciences / technology groups in a fast-paced regulated production environment. Broad experience in all process areas (HPAPI, Spray Drying, Lyofilisation, Milling&Micronisation, OSD, Sterile) 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. Experience overseeing/managing customer interaction from quotation up to project finalization in a fast paced CDMOs conducting clinical and commercial manufacturing. Proficiency in working with multicultural and cross-disciplinary project teamsExcellent knowledge of GMP, GCP, and ICH guidelines related to clinical and commercial Drug Substance manufacturing and bulk Drug product mainly for OSDDemonstrated ability to motivate and mentor peers and technical staff at CDMOs by fostering a culture of continuous improvement and operational excellence. Demonstrated expertise in the development of project plans for manufacturing transfers, including the ability to manage multiple projects. Location: Milan