QC Bioassay Principal Scientist

We are searching for a motivated and detail oriented QC Bioassay Principal Scientist to support quality control testing activities for biosimilars. This role is responsible for executing and troubleshooting cell based potency assay, ensuring compliance with regulatory and GMP standards, and contributing to continuous improvement initiatives within the QC laboratory. Key Responsibility: Independently accountable for completing assigned tasks and deliverables, while receiving direction and assignments from a supervisor. Demonstrates in-depth knowledge and proficiency in Bioassay (cell-based potency assays, ELISA, binding assays etc). Executing and troubleshooting cell based potency assays. Provide good technical input for Invalid assays investigations. Executes non‑routine activities, including deviations, change controls, CAPAs, and related investigation actions. Prepare testing protocols and reports, and review laboratory and cell bank documentation. Analyze, interpret, and document experimental data in line with ALCOA+ data integrity standards. Support qualification and optimization of critical reagents (e.g., reference materials) and technical troubleshooting Challenges and decisions are addressed collaboratively with cross‑functional teams, with solutions developed in partnership with the supervisor and other team members. Possesses expert knowledge of cell‑based assays, including relevant methods, techniques and associated procedural and process requirements. Provide technical training and support to team members and ensure proper understanding of laboratory methods and procedural requirements as needed. Support technology transfer and validation activities by contributing to the preparation and review of technical documents. Personally, authors and reviews key analytical sections related to potency methods within regulatory submissions, as well as responses to queries from health authorities and external partners. Requires familiarity with ALCOA+ principles to uphold data integrity in regulated environments, ensuring records are accurate, traceable, and audit ready. Qualifications and experience: Master’s degree or Ph.D in Biochemistry, Biotechnology, Biology, or a related field. Minimum 8 years previous experience with Potency/ cell-based assays. Knowledge and experience of working to GMP standards. Ability to work both independently and collaboratively in a fast-paced environment Communication skills: Excellent written and verbal communication...

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