Senior Scientist I - IA

Key Responsibilities:

· Design, develop, optimize and validate ADA and neutralizing antibody immunoassays on ELISA or MSD platforms.

· Independently troubleshoot assay performance issues and implement solutions.

· Lead method transfer, qualification and validation in line with regulatory guidelines (e.g., FDA, EMA, ICH M10).

· Ensure all laboratory work complies with Good Laboratory Practice (GLP) and internal SOPs.

· Maintain accurate experimental records, review data and contribute to technical reports.

· Train and mentor junior scientists.

· Work closely with clients, project teams, study directors and QA to deliver studies on time and to a high standard.

· Contribute to continuous improvement of laboratory processes, documentation and best practices.

· Take part in scientific discussions, audits and client meetings as needed.

· Perform other duties as required.

Required Qualifications:

· PhD in immunology, biochemistry, analytical chemistry or a related field with 3+ years of relevant industry experience, or an MSc with 5+ years.

· Proven experience developing and validating immunogenicity (ADA and NAb) methods in line with FDA and industry guidelines.

· Experience developing and validating PK or biomarker assays is advantageous.

· Strong troubleshooting skills, including root-cause identification.