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Senior Manager Analytical Method Transfer
vor 1 Monat
**Ihr Aufgabengebiet**:
- Oversee and guide analytical method transfer activities: team composition definition, transfer of documentation, knowledge transfer from donor site to receiving site including analyst training, feasibility experiments, risk/gap assessment, analytical method transfer protocol, experimental execution according to method transfer approach, evaluation of results, reporting, troubleshooting
- Establish product-specific analytical tech transfer strategy and plans with tech transfer team
- Assist in definition of site resource needs and get management approval via global technology transfer manager for the analytical transfer costs, strategies and timelines
- Track the progress and openly communicate updates, risks and mitigation strategies, build and sustain transparency with stakeholders and management
- Ensure timely availability of technical documentation pertaining to analytical transfers. Review analytical methods transfer documents as well as key project documents and coordinate technical input in relevant registration documents for accuracy and completeness as appropriate
- Ensure that Fresenius Kabi guidelines, Health Authority and GMP guidelines are met
**Wir erwarten**:
- Master in biochemistry, biotechnology, pharmacy, biophysics or similar
- Minimum 8 years in pharmaceutical/biotech company specializing in analytical method development / qualification / validation for DS or Drug Product Transfer
- Previous experience of multiple successful analytical method transfers of in-house methods between GMP sites
- Strong background in analytical science for biologics with a focus on physicochemical analytics
- 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, Proficiency in Spanish would be 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%)
**Wir bieten**:
- 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 70.000,-. The willingness to overpayment, according to skills and experience, is given
**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
