Quality Control Bioassay Specialist - Junior Analytical Project 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!
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.