Biotech Production Manager

vor 21 Stunden

Aubonne, Schweiz Merck KGaA Darmstadt Germany Vollzeit

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Votre rôle**:
Le (la) manager Production FSH organise le fonctionnement de son unité afin d'assurer la production du principe actif.

Il/elle assure et contribue à:

- La réalisation et suivi des projets Life Cycle du département Biotechnologie
- La résolution des déviations, la rédaction et le suivi des CCP's et CAPA's du département Biotechnologie
- Les investigations complexes du département Biotechnologie
- La gestion du parc d'équipements du groupe Production Campagne
- La mise en place de l'amélioration continue

**Activités principales**:

- Planifier, coordonner et superviser les activités de son unité.
- Contrôler que toutes les activités de son unité se déroulent en conformité avec les systèmes de qualité et de gestion en place
- Adapter les activités de son unité en fonction des exigences des systèmes de qualité et réglementaires
- Coordonner, superviser et effectuer la formation des collaborateurs en apportant son expertise
- Assurer les interfaces avec les différents départements à MSA et à l'extérieur
- Développer une vision et compréhension économique des activités de son unité
- Anticiper le développement de son unité et élaborer les projets et budgets nécessaires à la mise en œuvre de ces développements
- Garantir le bon fonctionnement du groupe pour supporter la fourniture des principes actifs avec la qualité requise selon les besoins du département
- Assurer le maintien constant du statut d'inspectabilité du groupe
- Garantir l'alignement de son groupe avec les objectifs du département Biotech et du site MSA

**Qui vous êtes**:

- Ingénieur ou PhD dans le domaine biotechnologie / sciences de la vie / chimie avec expérience professionnelle reconnue dans le milieu de l'industrie pharmaceutique d'au minimum 5 ans
- Connaissance des normes GMP et réglementation en vigueur pour la production des principes actifs
- Connaissance de l'environnement pharmaceutique et du niveau d'hygiène requis pour la production pharmaceutique
- Connaissance des principes de production de protéines dans un contexte de production pharmaceutique
- Connaissance des requis QA et RA pour la rédaction et l'approbation de document, des systèmes qualité
- Connaissances techniques sur la fonctionnalité des équipements et leur utilisation
- Connaissance des principes de qualification et validation, maîtrise technique des procédés dans son cadre d'activité
- Niveau courant en français et anglais

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Job Requisition ID: 258443

Location: Aubonne

Career Level: D - Professional (4-9 years)

Working time model: full-time

**North America Disclosure**

**Notice on Fraudulent Job Offers**
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.

**Job Segment**:Biology, Biotech, CAPA, QA, Quality Assurance, Science, Technology, Quality, Management

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