Strona główna

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.