QC Bioassay Principal Scientist

About the role

We are looking for 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, troubleshoot, and validate cell‑based potency assays, ELISA, and binding assays.
• Investigate invalid assays and provide technical input for deviations, change controls, and CAPAs.
• Prepare testing protocols, reports, and review laboratory and cell‑bank documentation.
• Analyze and document experimental data following ALCOA+ data‑integrity principles.
• Support qualification and optimization of critical reagents such as reference materials.
• Provide technical training to team members and ensure proper method understanding.
• 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.
• Strong written and verbal communication skills in English.
• Ability to work independently and collaboratively in a fast‑paced setting.

Required skills

• Cell‑based potency assays
• ELISA and binding assay techniques
• GMP standards
• ALCOA+ data‑integrity practices
• Microsoft Word and Excel
• PC proficiency

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.