As an ELISA Scientist I/II, you will be responsible for developing, establishing, validating, and executing bioanalytical methods used to support biopharmaceutical testing. This role requires strong laboratory skills, data analysis capabilities, and a commitment to scientific excellence and regulatory compliance.
The ideal candidate has hands-on experience with immunoassays and enjoys working in a collaborative, fast-paced laboratory setting where quality, accuracy, and client service are top priorities.
Key Responsibilities
- Perform and support method development, establishment, transfer, and validation activities for ELISA and multiplex ELISA assays.
- Execute bioanalytical testing using electrochemiluminescence (ECL) platforms and other immunoassay technologies.
- Generate, analyze, interpret, and review scientific data to ensure accuracy and compliance with cGMP requirements.
- Utilize software platforms such as SoftMax Pro and laboratory systems to process and evaluate assay results.
- Troubleshoot assay performance and identify opportunities for continuous improvement.
- Prepare technical documentation, protocols, reports, and validation summaries.
- Train and mentor laboratory personnel on established methods and best laboratory practices.
- Maintain accurate records in accordance with SOPs, regulatory requirements, and data integrity standards.
- Work effectively within a Laboratory Information Management System (LIMS).
- Collaborate with cross-functional teams to ensure projects are completed on schedule and meet client expectations.
- Support laboratory operations while maintaining a safe, organized, and compliant work environment.