Process Matter Experts Team Manager

Polpharma Biologics

Duchnice (pow. warszawski zachodni)

47 dni temu

#PolpharmaBiologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicine, offering new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us!

 

 

WE ARE LOOKING FOR:
Process Matter Experts Team Manager
Duchnice (pow. warszawski zachodni)
WHAT MAKES US SPECIAL
  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world

For our Technical Operations Department we are looking for a Team Manager who will take care of stable operations of the Process Matter Experts Team. On this position you will be responsible for performance of production and validation tasks. You will participate in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnology products. You will participate in manufacturing of biotechnology products in accordance with GMP principles and FDA requirements.

You will take care of:
  • Coordinating and managing a Team of Experts
  • Participation and monitoring of technology transfer processes and commercial production in accordance with the principles of cGMP and internal regulations
  • Compliance of all activities undertaken by the Team with the requirements of cGMP, FDA, EMA, ICH
  • Problem solving, explanation of deviations, implementation of changes in accordance with GMP and internal regulations. Supporting the Production Operational Team
  • Supporting qualifying activities, supervision of qualification documentation in accordance with GMP and internal regulations
  • Supervision of process and system documentation, ensuring an appropriate status enabling continuous work in accordance with the requirements of cGMP
  • Preparation and review of process documentation in accordance with GMP rules
  • Creating system documentation necessary for the smooth operation of the Active Substances Production Department in accordance with GMP standards
  • Close cooperating with the MSAT
  • Monitoring the progress of preparation for inspections / external and internal audits   
If you have:
  • Higher education in Biotechnology, Pharmacy or similar
  • At least five years’ experience in bioindustry and supervision of manufacturing process in accordance to GMP.
  • Excellent knowledge of USP and DSP Process
  • Experience in work with recombinant proteins
  • Experience in technology transfer processes and validation
  • Good knowledge of cGMP and FDA requirements
  • Experience in keeping and review process documentation and project documentation according to GMP requirements
  • Excellent knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage
  • Experience in managing a subordinate team, good organization of own work and subordinates
  • Fluent English                                  
  • Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks
Join our Team!
We offer
  • Sport Card
  • Development programs
  • Private healtcare
  • Relocation package
  • Fruit day
  • Integrations events
  • Benefit platform
  • and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Visit us
www.polpharmabiologics.com

Poznaj

Polpharma Biologics

#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.

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