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if you want to work:

in one of the most modern biotechnology
centres in Europe
 
in place where profesionals
from all over the world work
on the highest-quality equipoment
 
in the production
of biotechnological
drugs, which dive access
to effective therapy to
more patients
 
in a company that will dive you stable employment competetive remuneration attracive benefits and the opportunity to participate in training at home and abroad
 
Currently we’re looking for
Head of Microbial Plant

Join “start-up” Biologics division with strong international and local team at site!

 

 
We are waiting just for you!


 
 

What will you do?

  • Establish the new microbial facility including chose of production line, participation in engineering activities, supervision of SAT,FAT, IQ/OQ and PQ activities compliant with GMP regulations
  • Supervise the technology transfer of internally developed products and for CMO purpose
  • Build, lead, develop and motivate the team
  • Plan, monitor and improve the production processes and process quality
  • Coordinate issue identification and corrective action plans; and implement such plans to resolve project "issues" and maintain business commitments
  • Continuously improve process in every aspect compliant with internal and external regulations
  • Supervision the process validation
  • Represent Polpharma Biologics in business meetings with customers, partners, partnerships/joint development committees and professional societies
  • Preparation all necessary process documentation and documentation related to the process performance
  • Present the results on internal and external meetings
  • Establish all the necessary documentation to run the production and processes in microbial production according to internal quality system and GMP/FDA requirements
  • Regular report progress in production, issues, plans and challenges to the superior

What do we expect?

  • Proven track record in the technical development and production of therapeutic proteins in microbial expression systems
  • Experience with production scale-up and commercial scale production operations
  • Experience with technology transfer
  • Experience with stainless steel technology in production
  • GMP and FDA experience
  • Experience with single-use production equipment and with biosimilars would be an advantage
  • Fluency in English, knowledge of the Polish language would be an advantage
  • PhD in Biotechnology, Biochemistry or related field
  • Strong leadership skills
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