Pharmaceutical Development Manager - Gallicano, Italia - Kedrion Biopharma

Descrizione

Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

For the Global Pharmaceutical Development Department, we are looking for the following profile:
Global Pharmaceutical Development Manager The candidate will report to the Global Pharmaceutical Development Senior Director within the frame of Global Manufacturing and Science Development


Main Responsibilities:

• Strongly support the definition of technical strategy and implementation of key development work packages (, drug product formulation, lyophilization, primary packaging selection) for the global portfolio according to company's needs.
• Ensure cross-functional integration of key QbD principles/risk management according to global portolio's needs.
• Ensure proper planning/execution and technical management coordination for process/product and analytical development according to company's objectives.
• Supervision of QbD documentation for both DS and DP work-packages ( TPP, QTTP, CQA assessment, process risk assessments, control strategy).
• Provide technical and strategic expertise in area of responsibility (including process/product and analytical development) acting as the inter-face between development, management, operations, quality and regulatory functions.
• Responsible for writing regulatory packages for clinical/marketing authorizations with very limited supervision.
• Lead with limited supervision assigned projects and/or complex sub-projects according to product portfolio needs

Requirements:

• Degree in Life Science and/or PhD.
• At least 5 years' experience in Biopharmaceutical companies in product and process development.
• Strong competences in Drug Product formulation, primary packaging and lyophilization development and industrialization.
• Good skills in technical management and technical strategy definition.
• Very good knowledge of English (written and spoken).
• Excellent communication skills and ability to work in matrix organizations.