R&D Scientist/Engineer

14 ore fa

Caponago MB, Italia Corden Pharma - A Full-Service CDMO A tempo pieno

Join to apply for the Analytical Development Scientist role at Corden Pharma - A Full-Service CDMOCordenPharma is a leading company in pharmaceutical development and production; it produces active pharmaceutical ingredients (API), excipients, and finished and packaged pharmaceutical products with over 2,600 employees worldwide. Our services enable pharmaceutical and biotech companies to produce drugs with the ultimate goal of improving people's lives.We offer flexible and specialized solutions on five technological platforms: Peptides; We strive for excellence in supporting this network and are committed to providing high-quality products for patient well-being.Caponago is a chemical-pharmaceutical company that produces finished and bulk pharmaceutical products. The main functions include formulation and process development, industrial engineering and scalability, complex technology transfer, and new product launch.We cover all phases of the process, from preparation to aseptic filling and/or classified area filling and subsequent terminal sterilization to inspection, labeling, and packaging. Our service range includes project management, analytical method development and validation, and regulatory support in preparation for IMPD and CMC writing.We manage customer registration dossier applications in multiple countries, including deficiencies, maintaining relationships with various regulatory agencies throughout the approval process.Reporting to the Development Analytical Manager, the resource will be responsible for analytical method development and validation, and support for formulation development activities.In particular, the resource will be part of a project team, acting as a reference for all analytical activities.Plan, coordinate, and document, in collaboration with the Development team and under the supervision of the Development Analytics Manager, analytical method development, validation, and/or transfer activities according to existing procedures and regulations;Support formulation development and analytical transfer activities;Collaborate with clients, Project Managers, and the project team in planning the project and writing documents to support pharmaceutical development and technology transfer/industrialization of pharmaceutical production processes (Protocol/report on product development, technology transfer plan/report, etc.);Collaborate with the various functions involved in the project (QC, QA, Production, etc.) to implement project plan activities.Experience with QC methods for biological drug analysis and Mass Spectrometry is a plus;Good knowledge of English, written and spoken.The profile is completed by the ability and flexibility to manage multiple projects and excellent relational and communication skills.

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