Scientist, Bioassay Development jobs in United States
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Denali Therapeutics · 5 days ago

Scientist, Bioassay Development

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. The role involves developing, optimizing, and establishing potency assays for large molecule biotherapeutics, requiring hands-on experience in ligand-based and cell-based bioassays.

BiotechnologyGeneticsHealth DiagnosticsTherapeutics
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H1B Sponsor Likelynote

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

Qualification

Bioassay developmentCell-based bioassaysBinding assaysGMP regulationsAnalytical softwareProblem-solvingCommunication skillsOrganizational skillsCritical thinkingDetail-oriented

Required

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 and a deep commitment to improving the lives of patients with neurodegenerative diseases

Benefits

401k
Healthcare coverage
ESPP
A broad range of other benefits

Company

Denali Therapeutics

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Denali Therapeutics is dedicated to defeating neurodegenerative diseases to deliver safe and effective medicines to patients and families.

H1B Sponsorship

Denali Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (6)
2021 (5)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$1.32B
Key Investors
Royalty PharmaBaillie Gifford
2025-12-04Post Ipo Debt· $200M
2024-02-27Post Ipo Equity· $500M
2022-10-19Post Ipo Equity· $275M

Leadership Team

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Ryan Watts
CEO
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Peter Chin
Sr. Vice President & Head of Late-Stage Clinical Development and Medical Affairs
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Company data provided by crunchbase