Global Pharmaceutical Development Manager - Bolognana, Italia - Adhr

Adhr

Azienda verificata

Bolognana, Italia

5 giorni fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

LA SPECIALIZZAZIONE HEALTHCARE & PHARMA DI ADHR GROUP, RICERCA PER AZIENDA FARMACEUTICA:

Global Pharmaceutical Development Manager

Main Responsibilities:

Strongly support the definition of technical strategy and implementation of key development work packages (e.g., drug product formulation, lyophilization, primary packaging selection) for the global portfolio according to company's needs.
Ensure crossfunctional 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 workpackages (e.g. 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 interface 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 subprojects 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.

Location:
Bolognana, Gallicano (LU) con possibilità di smart working

Orario di lavoro full time