Shortfacts

Location Graz
Weekly hours Full-time
Entry date asap
Employment relationship unlimited

We are caring for our employees

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

Your contact person

Fresenius Kabi Austria
Frau Mag. Bettina Huber
Hafnerstraße 36
8055 Graz
https://karriere-fresenius-kabi.at

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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 skills and experience, is given

We are caring for our employees

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

Fresenius Kabi Austria
Frau Mag. Bettina Huber
Hafnerstraße 36
8055 Graz
https://karriere-fresenius-kabi.at