Technology Transfer Expert

Polpharma Biologics

Duchnice

6 dni temu

Technology Transfer Expert
Duchnice
Boost your career with us
Polpharma Biologics 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 medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Role:

As a Technology Transfer Expert you will be a part of MS&T Department at Polpharma Biologics Warsaw. Your role will be to lead and support the drug substance manufacturing technology transfers on PBW side.

Your responsibilities
  • Contribute to elaboration of pre-validation/validation strategy in alignment with process validation lead, including supportive studies;
  • Coordinate activities between departments involved in DS batches performed as a part of Technology Transfer;
  • Support Process Validation Lead/ Process Validation Expert in creation of validation protocol and report;
  • Initiate monitoring and ongoing process verification phase & compilation of first APQR;
  • Act as SPOC in RU for given technology transfer project;
  • Provide input into overall project strategy and plans including timelines and budget;
  • Establish TT plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Asses & plan site resources needs (FTEs, investments, external costs), strategies and timelines;
  • Form/lead project team, set priorities for project & project team meetings, coordinate project team activities, ensure that PBW guidelines, EHS and GMP guidelines are met;
  • Ensure that project tracking documentation/tools are updated according to plan;
  • Ensure timely availability of technical documentation;
  • Elaborate manufacturing process transfer main documents (protocol, report). Support creation of MBR and documents related to TT;
  • Review key documents & coordinate input for relevant registration documents for accuracy & completeness (as appropriate);
  • Contribute to HA inspection readiness;
  • Ensure the readiness for campaign start-up;
  • Establish and update procedures & templates for technology transfer;
  • Contribute to process improvement and optimizations for drug substance manufacturing technology transfers.
If you have
  • Higher education in the field: biotechnology, pharmacy or related;
  • Experience in Technology Transfer of manufacturing processes;
  • Excellent knowledge of GMP, EMA and FDA requirements and current technology transfer guidelines;
  • Practical knowledge of Technology Transfer in pharmaceutical production;
  • The ability to organize work well and to cooperate in a team;
  • Ability to identify and solve problems independently;
  • Very good knowledge of MS Office;
  • Very good command of the English language.
We offer
  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
Join our Team!
Why you should work with us
Contact us
career@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 
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