Aktuelle Jobs im Zusammenhang mit Senior Manager CMC Analytical Life Cycle Expert - Eysins - FRESENIUS_KABI
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Regulatory Affairs Senior Manager
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Dsp Director
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Senior Buyer
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Senior Buyer
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Senior Procurement Specialist
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Senior Buyer
vor 3 Wochen
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Senior Product Manager
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Senior Product Manager
vor 3 Wochen
Eysins, Schweiz AliveDx VollzeitJob Title: Senior Product Manager - AutoimmunityAbout the Role: AliveDx is seeking a highly skilled Product Manager to join our team in Eysins, Switzerland. As a Product Manager, you will be responsible for the management of our portfolio of autoimmunity diagnostic products.Main Responsibilities:* Develop and implement product strategies aligned with company...
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Senior Product Manager
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Senior Product Manager
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Eysins, Schweiz AliveDx VollzeitUnlock Your Potential as a Senior Product Manager at AliveDxAt AliveDx, we're revolutionizing diagnostic insights and transforming patient care. As a Senior Product Manager, you'll play a pivotal role in driving our autoimmunity diagnostic products forward.Your MissionAs a key member of our Product Management team, you'll be responsible for the entire...
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Senior Procurement Specialist
vor 1 Monat
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Senior Product Manager
vor 3 Monaten
Eysins, Schweiz AliveDx VollzeitAt AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ–– one of the first multiplexing and multimodality...
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Senior Procurement Specialist
vor 4 Wochen
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Strategic Procurement Manager
vor 2 Wochen
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Pricing Manager
vor 6 Monaten
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Senior Product Manager
vor 2 Wochen
Eysins, Schweiz AliveDx VollzeitLead Product Manager for Autoimmunity DiagnosticsAliveDx is seeking an experienced Product Manager to lead our autoimmunity diagnostic portfolio. This role involves developing and implementing product strategies, conducting market research, and collaborating with cross-functional teams to ensure successful product development and launch.Key...
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Department Leader, Procurement
vor 2 Stunden
Eysins, Schweiz AliveDx VollzeitAt AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba-- our blood bank reagents portfolio-- and MosaiQ®-- one of the first multiplexing and multimodality automated...
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Senior Product Manager
vor 3 Wochen
Eysins, Schweiz AliveDx VollzeitProduct Manager for Autoimmunity DiagnosticsAliveDx is seeking a Product Manager to join our team in Eysins, Switzerland. This role is responsible for managing our portfolio of autoimmunity diagnostic products, from market research and product development to launch and post-launch performance.Main Responsibilities:Develop and implement product strategies...
Senior Manager CMC Analytical Life Cycle Expert
vor 2 Monaten
About Fresenius Kabi Biosimilars
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. Our principle "we care for excellence" drives us to provide easier access to high-quality, affordable medicines to more patients around the world.
Your Role
As a Senior Manager CMC Analytical Life Cycle Expert, you will be responsible for supplying analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities for all aspects of CMC analytical packages.
Key Responsibilities
- 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.
Requirements
- Advanced scientific degree: Degree in biochemistry, bioanalytics and post grad training in respective fields. Further qualification such as MSc, PhD or specific vocational training would be an advantage.
- Fluency in English essential, both oral and written; additional languages (German or French) are an asset.
- Minimum 7 years experience in R&D in biopharma/biotech industry specializing in mAbs/protein analytics.
- Proven ability to rapidly understand experimental procedures, data, and concepts related to analytical development of biotherapeutics.
- Sound knowledge in GLP/GMP, ability to interpret guidelines and to implement compliant analytical packages in highly regulated markets, Familiarity with BLA/MAA filing and ICH guidelines required.
What We Offer
We offer a dynamic and challenging work environment with opportunities for professional growth and development. Our company is committed to diversity and inclusion, and we strive to create a workplace that is welcoming and inclusive for all employees.
Language
English (en-US)
