Responsable Culture Cellulaire (h/f)
Location
Huningue, Haut Rhin | France
Job description
About the role
Internal Role Title : Process Support Unit Lead
Location : Onsite About this role : We are looking for a Production Support Unit Lead who will be responsible for leading the support team for manufacturing and associated activities (~15/20 people) for the Cell Culture Production Unit / USP. He/she will be responsible for coordinating, planning, ensuring the execution and follow-up of all activities in the domain (expertise, project, improvement, training, resources, budget, compliance...).
Responsibilities: • Lead, mobilize and coach the Cell Culture Process Experts team; develop relationships of trust and respect and promote Novartis' values
• Promote change and actively stimulate collaboration between employees from different units
• Provide technical and scientific expertise related to cell culture / USP manufacturing process
• Ensure appropriate management of quality events within the given deadlines (escalation, description, investigation of the cause, impact and criticality evaluation, etc.); provide methodological and organizational support for major investigations or problems. And if necessary, lead the crisis cell.
• Manage risk analysis and gap assessment processes for the Cell Culture Unit and participate in defining specific quality (SQRA, QP, etc.) and safety (BCP, BBSP, etc.) roadmaps for the unit
• Ensure the production part of batch record review activities (production review, expert review)
• Ensure compliance of USP manufacturing unit activities with GMP and HSE rules, Novartis' quality/safety policies, quality and safety standards and procedures
• Support continuous improvement initiatives via science and technology, Lean Manufacturing, 6 Sigma; to increase unit performance in line with current and future objectives.
Role Requirements
Essential Requirements: • Degree in Pharmacy, Engineering, Chemistry, Biology, Biotechnology or related field (ideally an advanced degree) or completed vocational training with equivalent professional experience
• Minimum of 8 years of experience in the pharmaceutical or life sciences sector within a GMP environment, preferably in commercial manufacturing. Ideally, a minimum of 3 years of experience in an expert position within a GMP environment, good knowledge of the cell culture / USP manufacturing process
• Experience in team management/leadership, demonstrating real leadership skills
• Good communication, written and presentation skills
• Fluent in English
Desirable Requirements: • Goal-setting and performance management, Lean management
• Change management, adaptability, good resilience.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission andjoin us! Learn more here:
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teamsrepresentative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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