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GrazPermanentFull-time

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

Graz, Austria
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Your assignments

  • 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

Your profile

  • 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

At a glance

Location:

InternationalGraz

Career level:

Professional Experienced

Employment relationship:

PermanentFull-time

Division:

Fresenius Kabi

Reference number:

53599

Publishing date:

11/07/2022

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Your contact

Frau Mag. Bettina Huber
Fresenius Kabi Austria
Austria
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We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Careers with a purpose

When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.