Neurocrine Biosciences · 1 day ago
Scientist, Analytical Development
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$90K/yr - $123K/yr
2+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological disorders. The Analytical Development Scientist is responsible for developing, qualifying, and managing reference standards to support biologics and small-molecule programs, ensuring compliance with GMP and regulatory requirements.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develops, qualifies, and executes analytical methods for the characterization, qualification, and lifecycle management of reference standards and working standards for biologics and small-molecule programs, including compendial and non-compendial materials
Applies and optimizes compendial (USP/EP/JP) and non-compendial analytical methods to support identity, purity, potency, content, and stability testing of reference standards, drug substances, drug products, raw materials, and critical reagents
Supports method development, verification, and validation activities to ensure suitability of analytical procedures used for reference standard qualification and routine testing across development stages
Performs analytical testing using a variety of instrumental techniques (e.g., chromatography, spectroscopy, electrophoresis, and bioassays as applicable) in compliance with GMP, safety, and regulatory requirements
Evaluates analytical data, investigates atypical results, and contributes to documentation supporting reference standard qualification, change control, and regulatory submissions (IND/IMPD/NDA/BLA)
Collaborates with CMC, Analytical Development, Quality Control, and external vendors to ensure availability, comparability, and traceability of internal and compendial reference standards
Develops and executes instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials
Accurately follows established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
With supervision, plans and executes in-house stability studies for drug substance’s, intermediates, and prototype drug products
With supervision and as appropriate, assists/leads the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results
With supervision, collaboratively plans and executes cross functional studies for chemical development and formulation development
Recognizes and responds to unexpected or anomalous observations in all activities
Maintains complete and accurate records of laboratory work in conformance with company standard operating procedures (SOPs) and training
Provides detailed reviews of peer generated data as well as that generated from contracted service providers
Maintains the inventory of laboratory consumables and clean glassware
Coordinates vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintains complete and accurate records of instrument service and repairs in conformance with company SOPs and policies
Performs other duties as assigned
Qualification
Required
BS/BA degree in chemistry or closely related field and 2+ years of pharmaceutical industry experience in an R&D/QC setting, including conducting HPLC analysis and troubleshooting, evaluating analytical data and drawing meaningful conclusions
Proficient in using MS-Excel, MS-Word as well as data systems for computer-controlled instrumentation
Practical working knowledge of conducting HPLC analysis and troubleshooting
Some expertise in evaluating analytical data and drawing meaningful conclusions
Knowledge of cGMP expectations for laboratory records and quality systems
Ability to provide ideas for process improvements
Recognizes fundamental anomalies in data points and identifies issues in experiments / processes
Begins to understand how to think outside of the technical process and consider the impact decisions will have on the broader scientific goals
Strong knowledge of one scientific discipline
Good knowledge of scientific principles, methods and techniques
Good knowledge and demonstrated ability working with a variety of laboratory equipment/tools
Ability to work as part of a team of individuals to meet goals, tasks in a timeline driven setting
Strong computer skills
Good communications, problem-solving, analytical thinking skills
Detail oriented
Ability to meet deadlines
Good project management skills
Preferred
MS/MA degree in chemistry or closely related field preferred and some similar industry experience noted above
PhD in chemistry or closely related field and some industry or relevant experience a plus
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.
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