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Analytical development scientist

Caponago
Corden Pharma - A Full-Service CDMO
Pubblicato il 29 ottobre
Descrizione

PpJoin to apply for the bAnalytical Development Scientist /b role at bCorden Pharma - A Full-Service CDMO /b /ppbCordenPharma /b 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. /ppWe offer flexible and specialized solutions on five technological platforms: Peptides; Lipids and Carbohydrates; Injectables; High Potent and Oncology; Small Molecules. We strive for excellence in supporting this network and are committed to providing high-quality products for patient well-being. /ppbCordenPharma S.p.A. /b Caponago is a chemical-pharmaceutical company that produces finished and bulk pharmaceutical products. With its Caponago facility, Corden Pharma S.p.A. is a leader in the production of sterile dosage forms for injectable use. The main functions include formulation and process development, industrial engineering and scalability, complex technology transfer, and new product launch. /ppWe 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. We follow your pharmaceutical product distribution and complex supply chain in every phase of the process. /ppOur service range includes project management, analytical method development and validation, and regulatory support in preparation for IMPD and CMC writing. /ppWe manage customer registration dossier applications in multiple countries, including deficiencies, maintaining relationships with various regulatory agencies throughout the approval process. /ppReporting to the Development Analytical Manager, the resource will be responsible for analytical method development and validation, and support for formulation development activities. /ppIn particular, the resource will be part of a project team, acting as a reference for all analytical activities. /ph3MAIN ACTIVITIES AND RESPONSIBILITIES: /h3ulliPlan, 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; /liliSupport formulation development and analytical transfer activities; /liliCollaborate 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.); /liliManage the writing of analytical method validation protocols; /liliCollaborate with the various functions involved in the project (QC, QA, Production, etc.) to implement project plan activities. /li /ulh3REQUIREMENTS: /h3ulliDegree in Chemistry, Pharmacy, or related fields; /lili3-4 years of experience in a similar role; /liliKnowledge of laboratory methods (HPLC/UPLC, gas chromatography, etc.); /liliExperience with QC methods for biological drug analysis and Mass Spectrometry is a plus; /liliKnowledge of GMP; /liliGood knowledge of English, written and spoken. /li /ulpThe profile is completed by the ability and flexibility to manage multiple projects and excellent relational and communication skills. /ppWe offer an internal cafeteria, laptop, and a dynamic work environment. /ppIf you like working in a team and are interested in growing in a dynamic environment, if you naturally think and act beyond your scope, then you are in the right place! /p /p #J-18808-Ljbffr

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