Fresenius Kabi Austria, with headquarters in Graz and 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 1500 employees and ranges among the top enterprises of the region.
Senior Manager Drug Product Process Development and Manufacturing (m/f/d)
Your tasks
- Oversee and guide drug product activities including drug product process development, technology transfer, process characterization and validation and submission of CMC documents to Regulatory Authorities
- Define technical development that follows the principles of Quality by Design (QbD) and specify activities, milestones and costs
- Drive issue resolution in order to achieve Biosimilarity within the pre-defined analytical similarity corridor with respect to drug product attributes
- Provide scientific and technical operational guidance for drug product process development and manufacturing activities to the Biosimilars CMC team, Drug Product Process Development & Manufacturing Sites
- Provide technical and scientific oversight of licensed biosimilar drug product processes to ensure consistency of supply
- Build and sustain transparency with key internal and external stakeholders
- Develop and maintain scientific expertise in Biosimilars development including up-to-date knowledge of relevant CMC regulatory guidelines and requirements
Our expectations
- Bachelor in pharmacy, biotechnology, biophysics, biochemistry or similar and PHD (pharmacy, biotechnology, biophysics, biochemistry or similar)
- Minimum 8 years in pharmaceutical/biotech company specializing in drug product activities; preferably with at least part in a manufacturing setting. Previous experience working with biosimilars would be an advantage.
- Strong knowledge of biologics with a focus on drug product process development and manufacturing activities
- Good understanding of cGMP requirements, audits and HA interactions
- Ability to operate in a global matrix organization with various functions
- Skills in managing and influencing constructive interactions with key stakeholders across multiple cultures in a dynamic matrix environment
- Very good spoken and written knowledge of English and German, French is a plus
- Skilled problem solver
- Good interpersonal, networking and teamwork skills
- Excellent organizational and time management skills
- Critical thinking and proactive work style
- Willingness to travel (10-15%)
We offer
- Very varied area of responsibility in a complex environment
- Career opportunities in an international pharmaceutical company
- Training opportunities and personal development within the company
- Annual gross salary starting from EUR 65.000,-. The willingness to overpayment, according to skillsand experience, is given
Shortfacts
- Einsatzort: Graz
- Ausmaß: Full-time
- Eintrittsdatum: asap
- Anstellungsverhältnis: unlimited
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
Frau Mag. Bettina Huber
Hafnerstraße 36
8055 Graz
https://karriere-fresenius-kabi.at www.fresenius-kabi.com
