*Manufacturing Science
2 settimane fa
Job DescriptionPlanet Pharma are working with a biopharmaceutical organization that focuses on developing innovative medicines, particularly in areas of high unmet medical need. The company combines traditional pharmaceutical expertise with modern biotechnology, investing heavily in research and development to advance therapies for rare diseases and specialized conditions.Its portfolio includes both established treatments and novel biologics, with a strong emphasis on advancing science from discovery through clinical development and commercialization. The organization also operates manufacturing facilities to support its pipeline and collaborates with global partners to expand access to its therapiesDescriptionExecute technology transfer (incoming and outgoing), process scale‑up, and validation at industrial scale. Provide technical and scientific support during the commercial phase to resolve issues and ensure effective life cycle management.More responsibilitiesLead technology transfer projects from a technical perspective for products already registered.Perform process validation and re‑validation activities.Assess, in agreement with the line manager, the technical feasibility of new products, including industrial scale‑up and validation before and after registration.Conduct scale‑up studies and technical batches at industrial scale.Support the Quality team during audits by partners or regulatory authorities, acting as subject matter expert on technical aspects.Contribute to product maintenance projects addressing recurring issues, and collaborate on the introduction of new suppliers or third‑party providers.Carry out studies related to changes in critical product components (e.g., API, excipients, primary packaging) and manufacturing processes (e.g., batch size increase, process optimization, equipment changes) driven by external factors such as supplier changes, cost reduction, or business continuity.Provide technical and scientific input during preparation of CTD / NDA / BLA registration dossiers.Recommend corrective and preventive measures to strengthen process robustness, supported by feasibility studies and technical / economic analysis.Plan and oversee validation, re‑validation, verification, and periodic monitoring activities, consulting and reviewing the process validation master plan.Draft validation protocols and reports for process validation and monitoring activities.Prepare technology transfer plans, reports, and other documentation relevant to transfer activities.Collaborate with cross‑functional teams to resolve deviations and non‑conformities.Ensure compliance with applicable laws, ethical standards, regulations, and internal procedures.RequirementsPharmaceutical Science and Process Development knowledge and experience of most relevant dosage forms (OSD, Oral Liquid, Sterile)Statistics applied to pharmaceutical processesSpecific Scale up and Technology Transfer competenciesKnowledge and Experience in validation of pharmaceutical production processes in various dosage forms (OSD, Oral Liquid, Sterile)GMP standards knowledge.Fluent Italian and minimum working professional in EnglishAbout Planet PharmaPlanet Pharma offers a competitive referral scheme so you will be rewarded for your helpEqual opportunitiesWe are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion / belief, sexual orientation or age.#J-18808-Ljbffr
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