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:
If you have:
What we offer:
- 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.
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.