Drug Substance Senior Specialist
Duchnice (pow. warszawski zachodni)

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

A position supporting the production area in the field of problem solving and technology transfers in the area related to the GMM cell culture and isolation, and purification and formulation of biologically active substances produced with the use of GMM.

Your responsibilities

  • Optimizing production processes, explaining deviations, seeking technical and economic improvements, developing SDM.
  • Planning and conducting laboratory studies with particular emphasis on the proper selection of test methods and systems.
  • Responsibility for research equipment assigned to the area.
  • Accurate and complete documentation of the research.
  • Reporting results and conclusions during group, project and other meetings.
  • Participation in the creation and approval of documentation such as procedures, guidelines, risk assessments, specifications, reports.
  • Participation in project planning, including schedules and required resources.
  • Participation in technology transfers, implementation of changes in production - leading tasks related to your activities.
  • Providing training and support to junior team members.
  • Close cooperation with members of other teams (Analytical, TechOps, QA, QC, Regulatory, IT) and with external clients.

If you have

  • Higher technical education in the field of chemistry, industrial biotechnology, bioprocess engineering, biochemical engineering or related.
  • Several years of work experience in a R&D or manufacturing department with developing and scaling-up of drug substances manufacturing technologies with the use of GMM cultures.
  • Ability to conduct and optimize batch and fed-batch prokaryotic or eukaryotic cell cultures or processes of purification of biologically active substances in lab or semi-technical scale.
  • Ability to use automated culture or chromatographic and/or filtration systems (knowledge of „single-use” techniques will be an asset).
  • Knowledge of basic laboratory and analytical techniques used for control and culture process verification.
  • Knowledge Good Laboratory Practice.
  • Experience in GMP regulated area will be an asset.
  • Highly developed observation skills and ability of experiment planning.
  • Analytical thinking skills, formulating correct conclusions on the basis of the data sets obtained - experience in applying DoE methodology.
  • Experience in writing SOPs, complex protocols and technical reports.
  • Good command of English spoken and written.
  • Ability to work independently as well as a team leader.

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]