Sr. Scientist I

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We are seeking a Senior Bioanalytical Scientist with deep expertise in immunoassay method development and validation to support preclinical and clinical drug development. The ideal candidate will have a strong technical background in ligand-binding assays (e.g., ELISA, MSD), experience in troubleshooting complex technical issues, and a solid understanding of GLP/GCP standards. This role also includes mentoring and training junior scientists while driving scientific excellence and continuous improvement.

Responsibilities:

• Design, develop, optimize, and validate immunoassays (e.g., ELISA, MSD) for pharmacokinetic (PK), biomarker, and immunogenicity (ADA/NAb) studies.
• Independently troubleshoot assay performance issues and implement effective solutions.
• Lead method transfers, qualification, and validation activities in accordance with regulatory guidelines (e.g., FDA, EMA, ICH M10).
• Ensure all laboratory work adheres to Good Laboratory Practice (GLP) and internal SOPs.
• Maintain accurate and detailed experimental records, review data, and contribute to technical reports.
• Train and mentor junior scientists, supporting their technical and professional growth.
• Collaborate closely with project teams, study directors, and QA to ensure timely and high-quality study delivery.
• Actively contribute to continuous improvement in lab processes, documentation, and best practices.
• Participate in scientific discussions, audits, and client meetings as needed.
• Other tasks as required.

Skills, Education & Qualifications

• Ph.D. in immunology, biochemistry, analytical chemistry, or related field with 3+ years of relevant industry experience, or M.Sc. with 5+ years.
• Proven experience in immunoassay method development and validation (ELISA, MSD, or similar platforms).
• Strong troubleshooting skills with the ability to identify root causes and implement solutions.
• In-depth understanding of GLP, GCP, and regulatory requirements (FDA, EMA, ICH M10).
• Excellent documentation, data analysis, and scientific communication skills.
• Demonstrated ability to lead projects and support junior team members.
• Experience working in a CRO or pharmaceutical environment is a plus.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionScience and Research
• IndustriesBiotechnology Research and Research Services

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