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

Fresenius Kabi Austria

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

Permanent
Pharmaceutical industry
Health
Medical technology
Engineer
Technician
Published Over 4 weeks ago
 

Fresenius Kabi Austria

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

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