Bioassay Scientist/Sr. Scientist, Analytical Development jobs in United States
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Neurocrine Biosciences · 7 hours ago

Bioassay Scientist/Sr. Scientist, Analytical Development

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological disorders. The Bioassay Scientist/Sr. Scientist will act as the analytical potency subject matter expert, responsible for developing and managing potency assays to ensure key quality attributes are met throughout the drug development lifecycle.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Lead potency methods development, and qualification/validation activities to support characterization of antibody and antibody conjugate modalities utilizing various bioassays including but not limited to cell-based assays, ELISA, TR-FRET, qPCR, and SPR
Design, execute, analyze, and interpret bioassay data for process intermediates, drug substance, and drug product across all development stages
Represent Analytical Development as potency SME on CMC cross-functional teams and maintain accountability for analytical deliverables
Support analytical method transfer, manufacturing support activities, and technical interactions with external vendors and contract laboratories
Lab Personnel and ensure laboratory safety practices
Leverage literature, ICH/Regulatory guidance, and practical experience to perform this work and influence CMC development strategies
Other duties as assigned

Qualification

Analytical bioassaysPotency methodsCGMP complianceBioassay technologiesMethod developmentRegulatory requirementsInterpersonal skillsProblem solvingCritical thinking

Required

BS/BA degree in Biology or closely related field and 5+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting bioassay analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions OR
MS/MA degree in Biology or closely related field and 3+ years of similar experience noted above OR
PhD in Biology or closely related field and some relevant experience; may include post-doc experience
Strong knowledge of analytical bioassays and antibody-based drug development preferred
Hands-on experience with antibody and bio-conjugate modalities, with emphasis on analytical development and potency methods
Proficient in bioassay technologies, including but not limited to: cell-based assays (e.g., proliferation, inhibition, cytotoxicity, reporter/luciferase), immunoassays (e.g., ELISA, TR-FRET), binding assays (e.g., SPR) and molecular biology assays (e.g., qPCR)
Method development, qualification, validation, and transfer experience in Analytical Development
Comprehensive understanding of cGMP requirements in drug substance and drug product
Expert knowledge of cross-functional understanding related to drug development
Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
Excellent laboratory and productivity skills
Excellent interpersonal skills with strong oral and written communication abilities
Excellent problem solving and critical thinking skills

Benefits

Annual bonus with a target of 20% of the earned base salary
Eligibility to participate in our equity based long term incentive program
Retirement savings plan (with company match)
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage

Company

Neurocrine Biosciences

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Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.

H1B Sponsorship

Neurocrine Biosciences 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 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)

Funding

Current Stage
Public Company
Total Funding
$260M
Key Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO

Leadership Team

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Matt Abernethy
Chief Financial Officer
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Dimitri Grigoriadis
VP, Research
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Company data provided by crunchbase