Neurocrine Biosciences · 3 days ago
Senior Scientist, Analytical Development
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to developing life-changing treatments for patients with neurological disorders. The Senior Scientist in Analytical Development will lead analytical chemistry research, develop assays, and oversee all analytical activities to support the manufacturing of drug products for clinical studies.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Act as an analytical project leader
Responsible for all analytical activities for assigned project(s) to support manufacturing of API and drug products intended for use in preclinical and clinical studies (all phases)
Develops and validates test methods at NBI for drug substances (API), intermediates and drug product
Supports chemical development and formulation development
Preformulation collaboration to Pharmaceutical Sciences
Tests and provides a complete characterization of toxicology supplies
Structural characterization of drug substance molecules, identification of impurities/degradants in API and drug product
Audits and selects contract service providers (CSP) to conduct GMP analytical testing for Neurocrine projects
Analytical technology transfer to CSP
Overviews GMP analytical testing of clinical supplies by CSPs
Facilitates and leads investigations for out of specification and out of trend results
Prepares of the analytical sections of regulatory documents, protocols and reports
Provides training and/or supervision to junior staff, as needed
Other duties as assigned
Qualification
Required
BS/BA degree in chemistry or closely related field and 5+ years of experience in the pharmaceutical industry, focusing on analytical chemistry
Extensive hands-on experience in pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms
Previous supervisory and/or project management experience is preferred OR
MS/MA degree in chemistry or closely related field and 3+ years of similar experience noted above OR
PhD or equivalent in chemistry or closely related field and some relevant experience; may include postdoc experience
Effective report writing and oral presentations skills are required
Excellent written and verbal communication skills are required
Must be able to build excellent working relationships & maintain confidentiality regarding intellectual property and proprietary endeavors of the company
Ability to creatively solve complex problems in a team environment
Demonstration of cross-functional understanding related to drug development
Effectively see projects to completion
Understands how to effectively negotiate, persuade, and influence
Extensive knowledge of pharmaceutical analysis, methods development/validation for various active ingredients and/or dosage forms
A working knowledge of regulatory requirements for drug product commercialization, NDA preparation and cGMP, including knowledge of quality assurance/ quality control practices and issues
Must have working knowledge of ICH and FDA guidance for analytical method validation, stability, and CTD
Demonstrates solid level of understanding project / group goals and methods
Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes
Able to explain the process behind the data and implications of the results
Strong knowledge of one or more scientific disciplines, becoming expert in one discipline
Strong knowledge of scientific principles, methods and techniques
Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools
Ability to work as part of a team; may train lower levels
Ability to leading teams
Excellent computer skills
Strong communications, problem-solving, analytical thinking skills
Detail oriented yet can see broader picture of scientific impact on team
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
Strong project management 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 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.
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
Recent News
2026-01-06
Company data provided by crunchbase