Finde einen Job 
Finde eine Ausbildung 
Top Arbeitgeber 
Top Universitäten 
Für Unternehmen Auf einen Blick
- Aufgaben: Lead analytical expertise for mAbs/protein analytics in biosimilar product development.
- Arbeitgeber: Join Fresenius Kabi Austria, a top player in infusion therapy and clinical nutrition.
- Mitarbeitervorteile: Enjoy a full-time role with health promotion, free parking, and corporate events.
- Warum dieser Job: Be part of a global growth story with international career opportunities and impactful work.
- Gewünschte Qualifikationen: Advanced degree in biochemistry with 7+ years in biopharma/biotech, fluent in English.
- Andere Informationen: Competitive salary starting at EUR 65,000, with potential for overpayment based on experience.
Das voraussichtliche Gehalt liegt zwischen 65000 - 91000 € pro Jahr.
Fresenius Kabi Austria, with headquarters in Graz and a further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region. Shortfacts Einsatzort Graz Ausmaß Vollzeit Eintrittsdatum ab sofort Anstellungsverhältnis unbefristet We are caring for our employees * verlässlicher Arbeitgeber * starkes globales Wachstum * internationale Karrieremöglichkeiten * umfassende Aus- und Weiterbildung * aktive Gesundheitsförderung * Gratis Parkplatz * Kantine * gemeinsame Firmenevents Ihre Ansprechpartnerin: Fresenius Kabi Austria GmbH Frau Mag.Celina Gößler Hafnerstraße 36 8055 Graz www.fresenius-kabi.at Manager – CMC Analytical Life Cycle (m/w/d) Ihr Aufgabengebiet * Provide analytical expertise and know how in the field of mAbs/protein analytics to deliver industry leading analytical packages in support of Fresenius Kabi Biosimilar Product development of the required standard for adherence to Global Health Authorities (in particular US and EU) requirements * Collaborate with CMC Development teams, Regulatory Affairs and Quality functions to coordinate and deliver analytical packages against the project objectives * Work with subject matter experts to write and review analytical relevant sections of Health Authority submissions including BLA and MAA and post-approval variations * Drive best practice to ensure efficient and timely response to regulatory questions from within Analytical Development * Liaise with functional heads and Regulatory CMC to develop a portfolio of topic specific templates based on HA guidance documents and / or standard HA information request answers * Represent physchem analytics at Life Cycle Activities Committee * Manage direct/indirect interaction with Fresenius-Kabi Analytical Teams Wir erwarten * Advanced degree in biochemistry, bioanalytics and post grad training in respective fields * 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 * Proven experience representing analytical development in regulatory consultations for biosimilar products (preferably) and/or New Biological Entities in the EU/US * Significant exposure to and related analytics from Phase iii development to licensed Biopharmaceuticals including product life cycle management and product maintenance biotech manufacturing operations * Fluency in English essential, both oral and written; additional languages (German or French) are an asset Wir bieten * International challenges in a dynamic corporate environment * Corporate social events * Attractive performance-related salary package (annual gross salary starting at EUR 65.000,-, overpayment depending on occupational skills and experience) JETZT BEWERBEN
Manager - CMC Analytical Life Cycle (m/w/d) Arbeitgeber: Fresenius Kabi Austria GmbH
Kontaktperson:
Fresenius Kabi Austria GmbH HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Manager - CMC Analytical Life Cycle (m/w/d)
✨Tip Number 1
Make sure to highlight your experience in biopharma and biotech, especially with mAbs and protein analytics. This role requires a deep understanding of these areas, so be prepared to discuss specific projects you've worked on.
✨Tip Number 2
Familiarize yourself with the regulatory landscape, particularly GLP/GMP guidelines and BLA/MAA submissions. Being able to speak knowledgeably about these topics will set you apart during discussions.
✨Tip Number 3
Network with professionals in the field, especially those who have experience with Fresenius Kabi or similar companies. They can provide insights into the company culture and expectations for the role.
✨Tip Number 4
Prepare to demonstrate your collaborative skills, as this position involves working closely with various teams. Think of examples where you've successfully coordinated with others to achieve project goals.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Manager - CMC Analytical Life Cycle (m/w/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Manager - CMC Analytical Life Cycle position. Understand the key responsibilities and required qualifications, especially in the areas of mAbs/protein analytics and regulatory submissions.
Tailor Your CV: Customize your CV to highlight relevant experience in biopharma/biotech, particularly focusing on your expertise in analytical development and any experience with BLA/MAA filings. Use specific examples that demonstrate your ability to meet the job requirements.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background and skills to the specific needs of Fresenius Kabi Austria. Emphasize your experience in regulatory consultations and your understanding of GLP/GMP guidelines.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your language is professional and aligns with the expectations of the role, particularly in English, as fluency is essential.
Wie du dich auf ein Vorstellungsgespräch bei Fresenius Kabi Austria GmbH vorbereitest
✨Verstehe die Anforderungen
Mach dich mit den spezifischen Anforderungen der Position vertraut. Lies die Stellenbeschreibung sorgfältig durch und überlege, wie deine Erfahrungen und Fähigkeiten zu den geforderten Qualifikationen passen.
✨Bereite Beispiele vor
Sei bereit, konkrete Beispiele aus deiner bisherigen Berufserfahrung zu nennen, die deine Fähigkeiten in der analytischen Entwicklung und im Umgang mit regulatorischen Anforderungen belegen. Dies zeigt, dass du die nötige Expertise mitbringst.
✨Zeige Teamfähigkeit
Da die Rolle enge Zusammenarbeit mit verschiedenen Teams erfordert, solltest du betonen, wie du in der Vergangenheit erfolgreich mit anderen Abteilungen zusammengearbeitet hast. Bereite dich darauf vor, Fragen zur Teamarbeit zu beantworten.
✨Informiere dich über Fresenius Kabi
Recherchiere über Fresenius Kabi und deren Produkte, insbesondere im Bereich Biosimilars. Zeige dein Interesse an dem Unternehmen und dessen Zielen während des Interviews, um zu verdeutlichen, dass du gut ins Team passt.
