Senior Manager Drug Product Process Development and

vor 1 Woche

Graz, Österreich Fresenius Kabi Austria GmbH Vollzeit

**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 skills and experience, is given

**We are caring for our employees**:

- Reliable employer
- Strong global growth
- International career opportunities
- Comprehensive education and training
- Active health promotion
- Free parking space
- Canteen
- Joint company events

Fresenius Kabi Austria
Frau Mag. Bettina Huber
Hafnerstraße 36
8055 Graz

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