Global Pharmaceutical Development Manager
LA SPECIALIZZAZIONE HEALTHCARE & PHARMA DI ADHR GROUP, RICERCA PER AZIENDA FARMACEUTICA:
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 (e.g., 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 (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 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.
Location: Bolognana, Gallicano (LU) con possibilità di smart working
Orario di lavoro full time
Contratto : commisurato alla Seniority del candidato
Le ricerche sono rivolte a candidati dell’uno e dell’altro sesso ai sensi delle L.903/77 e L.125/91. I candidati sono invitati a leggere l’informativa privacy sul sito di Adhr Group ai sensi dell’art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
ADHR GROUP – Agenzia per il lavoro S.p.a. Iscr. Albo Agenzie per il Lavoro Sez. I – Aut. Min. prot.n.13/I/0013269.
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 (e.g., 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 (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 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.
Location: Bolognana, Gallicano (LU) con possibilità di smart working
Orario di lavoro full time
Contratto : commisurato alla Seniority del candidato
Le ricerche sono rivolte a candidati dell’uno e dell’altro sesso ai sensi delle L.903/77 e L.125/91. I candidati sono invitati a leggere l’informativa privacy sul sito di Adhr Group ai sensi dell’art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
ADHR GROUP – Agenzia per il lavoro S.p.a. Iscr. Albo Agenzie per il Lavoro Sez. I – Aut. Min. prot.n.13/I/0013269.
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