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Our team:
We at Site Frankfurt Biologics & Oncology (SFB&O) are future-oriented and work on the products of today and tomorrow.
Our product portfolio ranges from established oncology products to well-established monoclonal antibodies and development products. In addition, we work across sites with our colleagues around the world.
SFB&O is an industrialization and launch site for new biologics within the Manufacturing & Supply (M&S) Specialty Care network. The site is responsible for the implementation and launch of new products as well as the manufacturing of existing products. It also supports the Specialty Care network with QC testing according to the “Analytical Lead Site” concept.
The site is undergoing transformation to a fully integrated end-to-end (E2E) site with the implementation and commissioning of a new Microbial Launch Plant (MLP) for drug product manufacturing and the transition of the CAPI facility to M&S to take over API and drug product manufacturing.
A large part of the site’s activities will be the industrialization of new products in the form of active ingredients and pharmaceuticals and supporting clinical R&D care.
Main tasks:
• Validation of pharmaceutical processes including creation, review and approval of all relevant validation documents
• Accompanying the production process, bottling (isolator), control – high level of presence
• intensive cooperation with other departments (e.g. Regulatory Affairs, Quality Control, Engineering, QMS, MSAT) and coordination of measures
• Creation, review and approval of all master documents such as manufacturing documentation, master plans, SOPs
• Review of documents in daily business such as batch documentation, manufacturing records, logbooks
• Coordination of overarching problems and projects
• Training of colleagues
• Support with government inspections, customer and internal audits as an expert for manufacturing processes and validation/qualification
Education and professional experience
- Completed studies in natural sciences, preferably pharmacy or comparable
- Practical experience in the (aseptic) manufacture and/or testing of medicinal products
- Knowledge of the essential processes of a quality assurance system and the relevant pharmaceutical regulations
Social skills
- Independent and result-oriented work
- Making decisions and taking responsibility – high level of initiative
- Ability to work in a national and international team – working together transversally
- Strong communication skills and a strong desire to find advantageous solutions for the customer
- Independent, self-responsible work according to the valid GMP requirements
- Open to change, improvement and innovation
- Flexibility, high resilience and assertiveness
Languages
- Very good written and spoken German and English skills
Advancing science is our purpose. Every day. Always. But progress cannot happen without people – people from different backgrounds, in different places, in different roles, all united by one thing: the desire to create miracles.
At Sanofi, we promote equal opportunities for all, regardless of age, ethnic origin and nationality, gender and gender identity, physical and mental abilities, religion and belief, sexual orientation and social background or marital status.
In our ALL IN video and under www.sanofi.de Find out more about our programs for more diversity, equality and an inclusive working environment!
Become part of our great team!
Pursue progress. Discover extraordinary.
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch ‘One day at Sanofi’ and check out our Diversity Equity and Inclusion initiatives at sanofi.com
