Quality Control Bioassay Specialist - Junior Analytical Project Lead

Quality Control Bioassay Specialist - Junior Analytical Project Lead
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!

Key responsibilities for this role include:

  • Knowledge and Lab experience in some or all the following is an advantage; Inhibition of Proliferation assay, Potency assays, Binding assay, Maintenance of cell lines for cell-based bioassay and ELISA
  • Protocol generation and review – method Transfer / validation. 
  • Creation and revision of training material for the bioassay laboratory.
  • Perform laboratory investigations to determine root cause and Implement of appropriate corrective and preventative action.
  • Review and approval of bioassay analytical data.
  • Ensure that all laboratory operations are carried out in compliance with EHS, cGMP and regulatory commitments
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Promote and participate in the implementation and maintenance of relevant safety programmes

If you have:

  • BS or MS in Biotechnology, Biochemistry, Pharmaceutical Sciences or related field
  • 5 years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment
  • Knowledge in ICH/USP/EP/JP guidelines as it relates to QC methods, validation, stability, reference standards, specifications, and expiry dating
  • Strong verbal and written communication skills essential

What we offer:

  • Competitive salary;
  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more.


Why you should work with us
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