Central Lab Scientist II

Job Summary As a member of the Central Lab team, you will be primarily responsible for the development, optimization, validation, and testing of Potency Assays based on cellular and immunological principles, as well as ELISA, cell culture, and functional assays. You will help define validation requirements and establish compliant processes under the supervision of the line manager, enabling the Central Lab to successfully develop, validate, and deliver high-quality assays to support clinical trials and regulatory submissions. This role also offers the opportunity to closely collaborate with clinical trial teams as you define and execute the start-up activities required to establish these assay capabilities and technical expertise within the Central Lab. You will lead or contribute to method development, optimization, validation, and transfer of assays, including cell-based functional assays, ELISA, and other immunoassays, while ensuring full GLP compliance. The role involves performing mammalian cell culture, advanced analytical techniques (e.g., Flow Cytometry, qPCR/dPCR), and driving method transfer and validation from external partners. Additionally, you will be responsible for supporting computer system validation, ensuring data integrity, audit readiness, and regulatory compliance across lab operations. General Responsibilities: 1. Collaborate with external groups to identify technology, method evaluation and business processes that will establish potency assay expertise at Central lab. 2. Conduct analytical testing in compliance with established SOPs and relevant guidance. 3. Review data and evaluate against established acceptance criteria. 4. Define requirements for laboratory equipment and support purchasing. 5. Evaluate data to identify trends and/or establish limits. 6. Participant in discrepancy investigations and corrective actions. 7. Provide training to department team member, especially in potency assay techniques. 8. Lead assay development, optimization, transfer and validation activities. 9. Write, review or approve equipment qualification/maintenance life cycle documents. 10.Draft, check, review documents, such as SOP, protocol, analytical result, report and method under limited supervision. 11.Support internal, external, and regulatory inspections. 12.Other tasks assigned by line manager. Qualifications: Education and Experience: 1. Master’s degree in Biotechnology, Biochemistry, Pharmaceutical Sciences, Laboratory Science, or related field. 2. 3+ years of experience in potency assay, ELISA, and/or cell-based assay development, preferably from CDMO, CMO, CRO, or GMP-regulated laboratories. 3. Familiarity with assay development for vaccines, biologics, ADC, or cell therapies is a plus. 4. With direct experience in flow cytometry method development is preferred. 5. Demonstrated ability to apply knowledge of potency assay theories, principles, and techniques. 6. Medical technologist license is a plus, but not required. Skills and Competencies:  Strong expertise in assay validation, method lifecycle management, and data analysis.  Familiarity with clinical trial lab operations and regulatory compliance.  Excellent documentation skills for regulated environments.  Effective communication and collaboration with cross-functional teams and clients.  Strong troubleshooting and problem-solving abilities.  Good verbal and written communication in English.  Ability to manage multiple priorities and meet deadlines in a dynamic CRO setting.