Analytical Project Lead

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 new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us! www.polpharmabiologics.com

 

We are looking for:

Analytical Project Lead

 

You will take care of:

  • Being the single point of contact for all analytical topics within an project from development to product discontinuation.
  • Coordinating analytical activities and compiling analytical documents to support the project
  • Actively managing analytical knowledge of a certain 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 like quality attribute assessment, defining the stability profile of the molecule, structure function relationships
  • Overseeing and coordinating specific analytical activities of a certain project like: comparability studies, establishment of analytical standards, cleaning validation of manufacturing units
  • Participating in project team meetings and other project related meetings representing all analytical aspects of a certain project
  • Compiling documents like 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 development and QC and support interpretation of these data
  • Supporting any troubleshooting activities with analytical knowledge and coordinating and performing any analytical activities
  • Presenting analytical topics of a certain project during internal and external audits
  • Supporting preparation of regulatory submissions; participate in meetings with regulatory authorities as needed
  • Preparation, reviewing and approval of procedures, protocols and reports
  • Communication with any external companies to align on analytical tasks

 

If you have:

  • Higher education with a specialization in the fields: 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 biologic drugs (such as: peptide mapping, SEC, IEC), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopoeial methods used for release raw materials, intermediates and final drug products
    5 years’ experience in regulated laboratory environment (preferred biotechnological lab). Very good knowledge of GLP and GDP rules
  • Project management experience
  • Fluent English

 

Join our Team!

 

We offer:

  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more
Poznaj pracodawcę  
Polpharma Biologics S.A.
 

Polpharma Biologics S.A.

Analytical Project Lead

 
Miejsce pracy: Polska, Pomorskie, Gdańsk
 
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Ważna jeszcze 0 dni (do 2019-11-11)
 
 

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