Analytical Transfer Project Manager H/F

321778BR
Oct 04, 2021
France

Job Description

Le Centre de Biotechnologie de Novartis à Huningue est un pôle de référence dans la production de bio-médicaments, cliniques et commerciaux, par culture de cellules de mammifères.
Venez rejoindre un site de 650 personnes, au sein d’un environnement motivant et formateur

Your responsibilities:
Your responsibilities include, but are not limited to:
•We are seeking an Analytical Transfer Project Manager (ATPM) to lead analytical methods tech transfers, validations from development site to commercial site.
•The ATPM works within a matrix team environment, coordinating activities between Technical Research and Development department (TRD), Analytical Sciences and Technology department (AS&T) and Manufacturing science and technology department (MS&T).
•Expertise in analytical methodologies for large molecules associated with the in-process, release and stability testing of drug substance and drug products is required.
• In addition, skilled project management and communication skills are a necessary to be successful in this role.
•Understand of GMPs and requirements for working in GMP laboratories.
•Represent the Analytical Sciences and Technology department to the different comities and meetings
•Prepare the whole implementation of the analytical package in the manufacturing site according to Novartis global procedures, ICH, regulatory guidelines, pharmacopeia, and industry best practices to support process



What you’ll bring to the role:
•Define and lead the analytical transfer strategy in collaboration with Technical Research Development department
•Prepare, review and or approve analytical method validation and transfer protocols and reports ensuring sound scientific design, compliance with Novartis global procedures, ICH, regulatory guidelines, pharmacopeia, and industry best practices to support process.
•Track the progress of analytical method validation and transfer projects, openly communicate updates, risks and mitigation strategies to stakeholders and management.
•Assist or lead OOS and OOT investigations as a technical subject matter expert.
•Support the regulatory submission and answer to regulatory questions.
•Excellent project management skills and the ability to track multiple programs and projects simultaneously.
•Excellent communication skills with stakeholders, external partners and management.
•Ability to work independently with minimal direct supervision. Self-starter with a desire to achieve project objectives under aggressive timelines.

Diversity & Inclusion / EEO

Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.

Minimum Requirements

Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.
Novartis Technical Operations
NTO QUALITY
France
Huningue
Quality
Temps plein
Permanent
Non
321778BR

Analytical Transfer Project Manager H/F

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