DSP Process Matter Expert

Polpharma Biologics

Duchnice (pow. warszawski zachodni)

18 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:
DSP Process Matter Expert
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 DSP Process Matter Expert. On this position 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:
  • Elaboration, verification design and qualification documentation. Participation during equipment and systems qualification.
  • Elaboration of SOPs and manuals (including manuals to equipment).   
  • Documentation preparation according GMP rules and internal company requirements.
  • Participation in technology transfer and process validation in cooperation with MSAT and external Clients.
  • Running and monitoring the manufacturing process of biotechnology production according to GMP requirements, technological documentation and other internal requirements.
  • Coordination of production team in aim of effective resources utilization, conducting the trainings.
  • Close cooperation with the MSAT, Production Operational Department and Quality Department.
  • Supervision over schedules related to the preparation of GMP documentation in the Production Department - e.g. procedures, qualification documents, etc.
  • Supervision and issuance of system documentation in the Production Department.
  • Monitoring the progress of preparation for inspections and audits (external and internal) 
If you have:
  • Higher education in Biotechnology.
  • At least 5 years’ experience in biotechnological or pharmaceutical industry.
  • Good knowledge of cGMP and FDA requirements.
  • Experience in work with recombinant proteins in production scale.
  • Experience within protein purification processes. Knowledge of filtration and chromatography techniques.
  • Understanding of protein chemistry and interactions related with that.
  • Experience in keeping and reviewing process and project documentation according to GMP requirements.
  • Excellent knowledge of Single Use Technology used in biopharmaceutical production will be additional advantage.
  • Fluent English skills.
  • Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required.
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.

Poznaj stanowisko: Biotechnolog 
Biotechnologia, jak wskazuje sama nazwa tej dyscypliny nauki, ma na celu spożytkowanie wiedzy biologicznej w różnorodnych dziedzinach przemysłu i opracowywanie technologii, wykorzystujących substancje organiczne. Biotechnolog jest osobą opracowującą te technologie, oraz wdrażającą je w obrębie różnorodnych gałęzi przemysłu, a także modyfikującą, na podstawie posiadanej wiedzy i doświadczenia, technologie i metody już ...
Praca Biotechnolog