Global Pharmaceutical Development Manager

5 giorni fa

Lucca, Toscana, Italia Adhr A tempo pieno
Job Description

**Global Pharmaceutical Development Manager**

We are seeking a highly skilled and experienced Global Pharmaceutical Development Manager to join our team at Adhr Group. As a key member of our organization, you will be responsible for leading the development of pharmaceutical products and ensuring their quality and safety.

Main Responsibilities:

  • Technical Strategy and Implementation: Develop and implement technical strategies for pharmaceutical product development, ensuring alignment with company objectives and regulatory requirements.
  • QbD and Risk Management: Ensure the integration of Quality by Design (QbD) principles and risk management into pharmaceutical product development, ensuring compliance with global portfolio needs.
  • Process and Product Development: Oversee the planning, execution, and technical management of process and product development, ensuring timely delivery and quality standards.
  • Documentation and Regulatory Compliance: Supervise the creation of QbD documentation, including Technical Product Profiles (TPPs), Quality Technical Transfer Packages (QTTPs), and Control Strategy documents, ensuring regulatory compliance.
  • Technical Expertise and Leadership: Provide technical expertise and strategic guidance in pharmaceutical product development, acting as an interface between development, management, operations, quality, and regulatory functions.
  • Regulatory Packages and Project Management: Develop and submit regulatory packages for clinical and marketing authorizations, with minimal supervision, and lead assigned projects and complex sub-projects according to product portfolio needs.

Requirements:

  • Education: Degree in Life Science or PhD.
  • Experience: At least 5 years of experience in biopharmaceutical companies in product and process development.
  • Skills and Knowledge: Strong competences in drug product formulation, primary packaging, and lyophilization development and industrialization, good technical management and strategy definition skills, and very good knowledge of English (written and spoken).
  • Communication and Teamwork: Excellent communication skills and ability to work in matrix organizations.

Location and Working Conditions:

Full-time position, with the possibility of smart working, located in Bolognana, Gallicano (LU), with a commensurate contract based on the candidate's seniority.

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