Scientist, Bioassay Development

Scientist, Bioassay Development page is loaded## Scientist, Bioassay Development locations:
South San Franciscotime type:
Full time posted on:
Posted 16 Days Agojob requisition : R-1413

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

We are seeking a talented and experienced scientist to develop, optimize, and establish state-of-the-art potency assays for our diverse pipeline of large molecule biotherapeutics. The ideal candidate should have hands-on experience in ligand-based and cell-based bioassays to characterize activity and potency of a variety of modalities including antibodies and Fc-fusion proteins as well as potentially oligonucleotide-conjugates and virus-based gene therapies. The candidate will join a broader process development group with opportunities to closely collaborate on all aspects of analytical, formulation, and process development.
** Key Accountabilities/Core

Job 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/

Skills:

*** 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 (Graph Pad Prism, Soft Max 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 and a deep commitment to improving the lives of patients with neurodegenerative diseases.

Salary Range: $ to $ . Compensation for the role will depend on a number of factors, including a…