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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 Cell Culture

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

 

 
We are waiting just for you!


 
 

ROLE AND RESPONSIBILITIES:

  • Managing and supervision of the team
  • Supervision of technology transfer of processes to the cell culture plant for internal and CMO purposes
  • Monitor the production processes and process quality, and make improvements as needed
  • Coordinate issue identification and corrective action plans and implement such plans to resolve project "issues" and maintain business
  • Continuously improve process in every aspect compliant with internal and external regulations
  • Planning and Supervision of Process validation
  • Representation of Polpharma in business meeting with customer, partners, partnerships/joint development committees and professional societies
  • Regular reporting of progress in production, issues, plans and challenges to the superior
  • Representing the company during inspection of Cell culture plant
  • Process planning
  • Presentation of results on internal and external meetings
  • Establishment of documentation necessary to run production and processes in microbial production according to internal quality system and GMP/FDA requirements
  • Performing all duties with respect to current GMP requirements and other pharmaceutical regulations

REQUIRED QUALIFICATIONS:

  • Proven track record in production of therapeutic proteins in mammalian expression systems
  • Experience with process transfer and scale-up
  • Experience with single use technology
  • Experience with European and FDA inspection
  • Proven track record of participation in GMP inspection
  • Experience with Biosimilars of advantage
  • Fluency in English, knowledge of the Polish language of advantage
  • PhD in Biotechnology, Biochemistry or related field of advantage
  • Strong leader and developer of people
  • Knowledge about regulatory requirement for biosimilar products would be advantage
  • Experience in single use materials usage for biopharmaceutical production
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