Oferta pracy

Polpharma Biologics S.A.

Analytical Project Lead

Polpharma Biologics S.A.About the company

  • Gdańsk

    Gdańsk, Pomeranian
  • Valid for 14 days
    until: 06 May 2021
  • Remote recruitment
  • contract of employment
  • full-time
  • senior specialist (Senior), expert

Your responsibilities

  • Coordination of analytical activities and compilation of analytical documentation to support the project

  • Actively managing analytical knowledge of the project by communicating to all people involved in analytical activities and having an overview on these activities

  • Overseeing and coordinating method development, stability indicating studies, method qualification and validation, method transfer, method monitoring and improvement

  • Supporting all analytical activities to increase understanding of all properties of a molecule quality attribute assessment, defining the stability profile of the molecule and structure-function relationships

  • Overseeing and coordinating specific analytical activities of a certain project, i.e.: comparability studies, establishment of analytical standards

  • Participating in project team meetings and other project related meetings representing all analytical aspects of the project

  • Compiling documentation: product specifications, sampling plans, analytical method transfer protocols and reports, leachable and extractable studies

  • Supporting preparation of reports of other departments (e.g. USP development, DSP development, manufacturing) by providing analytical data collected in analytical departments, both R&D and QC, and support interpretation of these data

  • Supporting any troubleshooting activities with analytical knowledge

  • Coordinating and performing analytical activities

  • Presenting analytical topics related to the project during internal and external audits

  • Supporting preparation of regulatory submissions as well as participation in meetings with regulatory authorities as needed

  • Preparation, reviewing of procedures, protocols and reports

  • Communication with external companies to align on analytical tasks

Our requirements

  • University degree (biotechnology, analytical chemistry, biochemistry, pharmacy, or related)

  • Practical and theoretical knowledge about development, transfer and validation of analytical methods, stability studies, liquid chromatography concerning work with biological drugs (such as: peptide mapping, SEC, IEC, HILIC), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopeial methods used for released raw materials, intermediates and final drug products

  • 5 years’ experience in regulated laboratory environment (biotech lab preferably)

  • Very good knowledge of GLP and GDP rules

  • Project management experience

  • Fluent English

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • sharing the costs of professional training & courses

  • life insurance

  • remote work opportunities

  • flexible working time

  • fruits

  • integration events

  • retirement pension plan

  • preferential loans

  • coffee / tea

  • extra social benefits

  • shopping coupons

  • holiday funds

  • redeployment package

  • christmas gifts

  • birthday celebration

  • employee referral program

  • extra leave

Polpharma Biologics S.A.

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!

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This is how we work
This is how we work