Senior Manager Drug Product Process Development and Manufacturing (m/f/d), Graz

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.

Missions

• 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

Profil

• 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