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(Senior) Manager CMC Analytical Life Cycle
vor 1 Monat
At Fresenius Kabi Biosimilars, we want to make a difference. With our principle "we care for excellence" we relentlessly strive to provide easier access to high-quality, affordable medicines to more patients around the world.
Being part of Fresenius Kabi, we are a global company with strong growth opportunities and a unique expertise in healthcare, which allows for a wide range of demanding and varying tasks. We develop products with a focus on autoimmune diseases and oncology.
We work together in a spirit of teamwork, personal commitment and integrity to create value. We combine an entrepreneurial leadership approach with a lean hierarchy, diversity, and talented individuals.
At Fresenius Kabi Biosimilars, we believe that every single one of our 200 employees counts and makes a difference on a daily base. Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer and Top Employer.
Your assignments
Functional Goal:
Supply Analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities for all aspects of CMC analytical packages.
Oversee and be responsible for responding to questions from regulatory authorities related to method performance, validation and transfer, stability, release specifications and interpretation of comparability and similarity data in co-ordination with the appropriate experts.
Author, review and validate analytical CMC sections of dossiers delivered to regulatory agencies from analytical data/source documents, ensuring cGMP compliance and data integrity in line with Fresenius Kabi's corporate quality standards.
Interface with CROs and CMOs to ensure analytical life cycle maintenance and security of licensed product supply to the approved quality standard.
Main Tasks:
Your profile
Qualification Profile:
Education & Languages
Professional Skills and Experience
Personal Skills & Competences
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