Scientist, Bioassay Development

Role Summary

Scientist, Bioassay Development responsible for developing, optimizing, and establishing state-of-the-art potency assays for a diverse pipeline of large molecule biotherapeutics. The role requires hands-on experience with ligand-based and cell-based bioassays to characterize activity and potency of modalities including antibodies, Fc-fusion proteins, and potentially oligonucleotide-conjugates and virus-based gene therapies. The candidate will collaborate within a broader process development group on analytical, formulation, and process development activities.

Responsibilities

• Lead the design, development, and optimization of cell-based and biochemical bioassays to evaluate potency and activity of therapeutic products
• Develop, optimize, and qualify bioassays for product release and stability testing; support bioprocess and formulation development and product characterization activities
• Serve as subject matter expert (SME) for potency assays; promote innovation and explore novel approaches for developing and troubleshooting complex assays
• Maintain complete and accurate records and contribute to continuous process improvement
• Represent the Bioassay team cross-functionally and drive bioassay method development through internal and external collaborations
• Present experimental results in team meetings
• Record and analyze experiments in an electronic laboratory notebook (ELN)
• Coordinate parallel tasks across multiple projects and prioritize deliverables to meet goals

Qualifications

• Required: B.S./M.S. in a 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
• Required: 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
• Required: 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 (ICH Q2(R2), USP)
• Required: Demonstrated ability to independently design experiments and resolve technical challenges
• Required: Innovative mindset with experience introducing new technologies and process improvements in bioassay development
• Required: Proficient with electronic lab notebooks and analytical or statistical software (GraphPad Prism, SoftMax Pro, PLA 3.0, JMP)
• Required: Able to manage competing priorities and thrive in a fast-paced, dynamic environment
• Required: Excellent laboratory, analytical, and organizational skills with strong critical thinking and problem-solving ability
• Required: Exceptional oral and written communication skills
• Required: Motivated, detail-oriented, and intellectually curious scientist with a creative approach to problem solving and a deep commitment to improving lives of patients with neurodegenerative diseases

Education

• B.S. or M.S. in a relevant scientific discipline, or Ph.D. in a related field