Scientist, Bioassay Development

Role Summary

Scientist, Bioassay Development. Develop, optimize, and establish state-of-the-art potency assays for a diverse pipeline of large molecule biotherapeutics. Lead design and execution of cell-based and biochemical bioassays to evaluate potency and activity; serve as SME for potency assays; contribute to process development and product characterization activities.

Responsibilities

• Lead the design, development, and optimization of cell-based and biochemical bioassays to evaluate the potency and activity of therapeutic products
• Developing, optimizing, and qualifying bioassays for product release and stability testing as well as supporting bioprocess and formulation development, and product characterization activities
• Serve as subject matter expert (SME) for potency assays, promoting innovation and exploring novel approaches for developing and troubleshooting complex assays
• Maintaining complete and accurate records and contribute to continuing process improvement
• Representing the Bioassay team cross-functionally and continuously drive Bioassay method development through internal and external collaborations
• Presenting experimental results in team meetings
• Detailed recording and analysis of experiments in an electronic laboratory notebook (ELN)
• Coordinating parallel tasks across multiple projects and prioritizing deliverables to meet departmental and organizational goals

Qualifications

• B.S./M.S. in relevant scientific discipline with a minimum of 5 years of direct CMC bioassay development experience in biotech/biopharma or Ph.D. with 1+ years of directly relevant experience
• Direct experience developing and optimizing binding and functional cell-based bioassays using platforms such as ELISA, HTRF, DELFIA, or qPCR to measure target engagement, cellular uptake, and transcript-level modulation
• Demonstrated expertise in phase-appropriate assay transfer, qualification, and validation within a CMC and GMP-regulated environment
• Strong understanding of regulatory expectations for bioassay development and validation (e.g., ICH Q2(R2), USP)
• Demonstrated ability to independently design experiments and resolve technical challenges
• Innovative mindset, with experience introducing new technologies and process improvements in bioassay development
• Proficient with electronic lab notebooks and analytical or statistical software (GraphPad Prism, SoftMax Pro, PLA 3.0, JMP) is essential
• Adept at managing competing priorities and thriving in a fast-paced, dynamic environment
• Excellent laboratory, analytical, and organizational skills, with strong critical thinking and problem-solving ability
• Exceptional oral and written communication skills
• Motivated, detail-oriented, and intellectually curious scientist with a creative approach to problem solving

Skills

• Bioassay development and optimization
• Cell-based and biochemical assay design
• ELISA, HTRF, DELFIA, qPCR platforms
• Assay transfer, qualification, and validation
• Regulatory awareness (ICH Q2(R2), USP)
• ELN documentation and data analysis
• Strong communication and collaboration

Education

• B.S. or M.S. in a relevant scientific discipline; or Ph.D. with applicable experience

Additional Requirements

• None beyond listed qualifications