Principal Scientist, Analytical Development jobs in United States
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Neurocrine Biosciences · 13 hours ago

Principal Scientist, Analytical Development

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to developing life-changing treatments for patients with neurological disorders. The Principal Scientist in Analytical Development will lead analytical activities for drug substance and product development, focusing on bioconjugates and peptides while ensuring compliance with regulatory standards.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Lead analytical development activities for the characterization of synthetic peptides and bioconjugates utilizing LC-MS, MS/MS, Capillary Electrophoresis, iCIEF, SEC, peptide mapping, and modern glycoprotein & carbohydrate characterization techniques
Lead analytical methods development and qualification involving process validation and the validation of analytical methods within cGMP compliance in support of preclinical through commercialization
Represent Analytical development on cross-functional teams. Maintain accountability for analytical deliverables and progress on CMC and manufacturing plans for all development projects
Conduct laboratory work independently and/or train lab personnel within the company and at external vendors
Ensure safe laboratory practices
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
Authorize analytical related CMC regulatory documents and lead the 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

Analytical ChemistryBioconjugatesPeptide CharacterizationCGMP ComplianceMethod DevelopmentRegulatory KnowledgeLaboratory SkillsInterpersonal SkillsCommunication Skills

Required

BS/BA in Analytical Chemistry/Biochemistry/Cell & Molecular Biology or related discipline and 15+ years of experience in the analytical/pharmaceutical development field OR
MS/MA in Analytical Chemistry or related discipline and 13+ years of experience OR
PhD in Analytical Chemistry or related discipline and 7+ years of relevant experience; may include postdoc experience
Expert knowledge and understanding of analytical chemistry, bioanalysis, and a thorough understanding of bioprocess as well as formulation development
Experience and expertise with peptides compounds and conjugates, including analytical controls in peptide synthesis, conjugation process, formulation of injectable biologics, and process characterization
Excellent interpersonal skills with strong oral and written communication abilities
Excellent laboratory and productivity skills
Proficient in characterization of peptides and/or conjugates compounds using various modern technologies. They may include but not limited to LC (RP, SEC, IE), LC-MS, Capillary Electrophoresis, peptide mapping, Mass Spectrometry, SDS-PAGE, ELISA, gel electrophoresis and modern glycoprotein & carbohydrate characterization, cell-based potency assays
Method development, validation, qualification, 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

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

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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