Neurocrine Biosciences · 19 hours ago
Principal Scientist, Analytical Development
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$131K/yr - $179K/yr
4+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients. The Principal Scientist will lead analytical development for multiple projects, focusing on gene therapy and biologics, ensuring compliance with regulatory requirements and advancing innovative analytical techniques.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead analytical development and characterization activities for multiple projects with focus on gene therapy and biologic compounds, Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
Design, plan, and execute activities towards the goals of one or more analytical development projects to support pre-clinical through commercial activities
Execute characterization of gene therapy and biologic modalities using high-resolution mass spectrometry, chromatographic separations, and other biophysical methodologies
Perform laboratory work and/or direct lab personnel within the company and at external vendors
Ensure safe laboratory practices
Perform analytical development and methods optimization in support of preclinical through commercialization
Create and implement novel concepts and techniques to support analytical activities with Chemical and Product Development
Support off-site analytical transfers, manufacturing support, and interaction with contractors
Provide input into CMC regulatory documentation and supporting work
Leverage literature, ICH/ Regulatory guidance, and practical experience to perform this work and influence CMC strategies
Contribute to development of policies and department strategies
Build and enhance internal and external professional relationships
Support career development and technical growth of team members
Present finding at varying levels across the company
Other duties as assigned
Qualification
Required
BS/BA and 12+ years of experience, or OR
MS/MA and 10+ years of experience, or OR
PhD or equivalent and 4+ years of relevant experience
Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development
Method development, validation, and transfer experience in Analytical Development
Proficient in characterization of gene therapy and/or biologic compounds using various modern technologies. They may include but not limited to high-resolution MS, SEC, CE (icIEF/CE-SDS), SV-AUC, DSC, CD, and plate-based assays
Experience and expertise with gene therapy and/or biologic compounds, including cell line banks, plasmids, viral vectors, and residual host cell proteins/DNA
Excellent interpersonal skills with strong oral and written communication abilities
Excellent laboratory and productivity skills
Knowledge of FDA, EMA, WHO, and ICH regulatory requirements
Comprehensive understanding of cGMP requirements in drug substance and drug product
Expert knowledge of cross-functional understanding related to drug development
Benefits
Annual bonus with a target of 30% 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 in accordance with the terms and conditions of the applicable plans
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
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 CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
2026-01-06
Company data provided by crunchbase