USP Production Team Leader

Polpharma Biologics

Duchnice (pow. warszawski zachodni)

14 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:
USP Production Team Leader
Duchnice (pow. warszawski zachodni)
WHAT MAKES US SPECIAL
  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world

The USP Production Team Leader is responsible for participation in the production process of biotechnology products in accordance with the GMP principles and FDA requirements to obtain a product of the specified quality in the specification for registration. Participation in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of internal and external biotechnology products. Managing of Operator's work during the shift.

 

You will take care of:
  • Participation in the design process, implementation of the production area,
  • Responsibility for the purchase, qualification of production equipment,
  • Experienced in technology transfer in accordance with cGMP regulations and internal during the implementation of projects related to the introduction of new biotechnology products,
  • Manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification,
  • Elaboration of SOPs and manuals ( including manuals to equipment),
  • Running and monitoring the manufacturing process of biotechnology product according to GMP requirements, technological documentation and other internal requirements,
  • Writing Completion and Review of cGMP paperwork, (SOPs, Batch Records),
  • Attending of process validation in cooparation with Reaserch and Developmet Department/ Client,
  • Organizing your and team's work in order to make the most effective use of working time and performance of tasks,
  • Leads the shift group and responsible of team members.
If you have:
  • Higher education (at least Msc) in Biotechnology, Pharmacy or similar,
  • At least 5 year experience in biotechnological or pharmaceutical industry
  • 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 with mammalian cell culture. Additional advantage will be performing cultivation in production scale according to GMP rules.
  • Very good speaking and writing English skills,
  • Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required,
  • Knowledge of MS Office and AutoCAD.
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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