BIOSAFETY STEWARD (H/F)

323963BR
Oct 04, 2021
France

Job Description

10 million doses, this is what the Huningue Biotechnology Center produces every year, which is a reference center in the production of bio-drugs, clinical and commercial, by growing mammalian cells.
"Quality and safety depend of course on our high-tech equipment, but they also and above all come from our teams, who bring innovation and improvement for the patient," explains Paula Rosa, site manager.
Come and join a committed team of 700 people, in a motivating environment
This role will aim to manage and coordinate all activities related to the identification and management of microbiological risks (bacteria, viruses, other agents) on the production site including management of the respective microbial control strategy of the processes for the site, as well as management of the evaluation and improvement of the identification of microbiological risks and their mitigation.

As such, your responsibilities include - but are not limited to:
• Development and maintaining microbial risk assessments for the manufacturing processes of active substances (DS) for biological products on site (clinical and/or commercial phase)
• Supporting the Production teams in root cause investigations and continuous improvement activities to reduce microbiological risks on site.
• Participating in transfers and launches, liaising with technical development functions for new products and aligning with the microbial risk approach
• Supporting the process validation team in definition, implementation and closure of hold time time studies of production products and intermediates to ensure the absence of microbiological risks
• Promoting the application of appropriate behavior and c-GMP rules during manufacturing to avoid increased microbiological exposure of products during manufacturing.


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

What you will bring to the role:
• M.Sc. or Ph.D. in Biotechnology, Bioengineering, Pharmacy or equivalent, with minimum 8 years of experience in the field of manufacturing / science and production technology / technical development / quality

Desirable requirements:
• Familiarity with GMP requirements
• Fluent English and French (read, written, spoken)
• Master/Diplôme d’ingénieur en biotechnologie, biochimie ou industrie pharmaceutique

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's
lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital
innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and
flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!


Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
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:

https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO LARGE MOLECULES
France
Huningue
Technical Operations
Temps plein
Permanent
Non
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323963BR

BIOSAFETY STEWARD (H/F)

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