Overview In this role you will develop, qualify, validate, and execute bioassays for biologic drugs in a regulated lab. You will work within a cross-functional team to support drug development programs and client-focused projects. The position emphasizes method development, assay validation, and data integrity in a cGMP setting. You will contribute to continuous improvements and leverage immunoassay platforms to deliver high-quality results. This is an opportunity to impact how biologics are evaluated and released in a global testing environment.
Compensation / Benefits- Medical, dental, and vision coverage
- Company-paid life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Employee assistance programs
- Career development and advancement opportunities
Responsibilities- Perform routine and non-routine bioassay testing under cGMP, following SOPs and study protocols
- Develop, optimize, qualify, and validate bioanalytical methods for biologic drug programs
- Execute and troubleshoot immunoassays (ELISA and multiplex) using ECL platforms
- Analyze, interpret, and document experimental data using laboratory software and statistics tools
- Prepare technical reports, validation documents, study records, and lab notebooks
- Maintain data integrity and regulatory compliance
- Use LIMS for sample tracking and documentation
- Collaborate with cross-functional teams to meet project milestones and client timelines
- Train and mentor junior scientists and staff as needed
- Participate in investigations, method improvements, and continuous process enhancements
Key requirements- Bachelor's degree in Biology, Biochemistry, Biotechnology, Cell Biology, Immunology, or related field with 0-2 years of experience (Scientist I) or 2+ years (Scientist II) or a Master's with relevant experience
- Authorization to work in the United States without sponsorship
- Experience with ELISA, multiplex ELISA, MSD, or other ligand-binding assays is preferred
- strong organizational and time management
- problem-solving abilities
- excellent written and verbal communication
- ELISA and multiplex immunoassays
- electrochemiluminescence (ECL) platforms
- bioassay development, qualification, and validation principles
