QC Bioassay Principal Scientist

About the role

We are seeking a motivated and detail‑oriented QC Bioassay Principal Scientist to lead quality control testing for biosimilars. The role focuses on executing and troubleshooting cell‑based potency assays while ensuring compliance with regulatory and GMP standards.

Key responsibilities

• Execute and troubleshoot cell‑based potency assays, ELISA, and binding assays.
• Investigate invalid assays and provide technical input for deviations, change controls, CAPAs, and related investigations.
• Prepare testing protocols, reports, and review laboratory and cell bank documentation.
• Analyze, interpret, and document experimental data following ALCOA+ data‑integrity principles.
• Support qualification and optimization of critical reagents such as reference materials.
• Provide technical training and support to team members.
• Contribute to technology transfer, validation activities, and regulatory submissions.

Required profile

• Master’s degree or Ph.D. in Biochemistry, Biotechnology, Biology or related field.
• Minimum 8 years of experience with potency/cell‑based assays in a GMP environment.
• Excellent written and verbal communication skills in English.
• Ability to work independently and collaboratively in a fast‑paced laboratory.

Required skills

• Cell‑based potency assays
• ELISA and binding assay techniques
• Good Manufacturing Practice (GMP) compliance
• ALCOA+ data‑integrity standards
• Microsoft Word and Excel proficiency
• PC literacy

What we offer

• Opportunity to work on ambitious projects that impact patients' lives.
• International, diverse, and inclusive work culture.
• Positive, flexible, and innovative environment supporting personal growth.