MS&T DSP Process Lead
Gdańsk

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!

Your role

Our Manufacturing Sciences & Technology group is looking for a new team member. On this position you will be at the interface between development, production and quality and become the process data expert by thoroughly analyzing, comparing development and manufacturing data and putting it under quality perspective being involved in process transfer, process validation and ongoing process verification activities.

Your responsibilities

  • DSP data collection and analysis during technology transfer, process validation and ongoing process verification;
  • Preparation for DSP process validation/ongoing process verification including relevant risk assessments;
  • Generation of process validation and ongoing process verification plans and DSP related protocols/reports in close collaboration with development and production teams;
  • Providing technical input into deviation investigations, CAPA implementations and change controls;
  • Development, maintenance and continue improvement for DSP process;
  • Participation in continuous improvement of products and risk mediation;
  • Review and support definition of CPP and KPP and Process Control Strategy;
  • Support during Process Transfer activities;

If you have

  • Good knowledge of biomanufacturing processes for microbial or mammalian DSP technology;
  • Minimum five years of experience in the production/development of biotechnological products;
  • Experience with working under GMP - good knowledge of cGMP and FDA requirements for biologics manufacturing, validation and technology transfer requirements;
  • Knowledge of analytical methods, process control understanding;
  • Good communication skills both verbal and written;
  • Excellent team player spirit;
  • Action orientation and drive for results with good organizational skills;
  • Curiosity and attention to details;
  • Experience by working in multidisciplinary teams;
  • Fluent English.

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
[email protected]