Neurocrine Biosciences · 1 hour ago
Scientific Director, Analytical Development
San Diego, CA
Full-time
Onsite
Director/Executive
$189K/yr - $257K/yr
7+ 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 Scientific Director, Analytical Development will lead analytical activities and strategy for drug substance and drug product development while providing scientific leadership to junior staff and ensuring compliance with regulatory requirements.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Leads analytical development activities for small molecules and peptides and serves as the analytical representative for cross-functional technical development teams which will include representatives from pre-formulation, formulation development, synthetic process development, manufacturing, regulatory CMC and quality assurance organizations
Oversees analytical method development, validation and transfer, specification strategy, GMP testing, and stability studies for drug substance and drug product internally and externally
Directs the use of established and new techniques including HPLC/UPLC, LC-MS, GC, spectroscopy, NMR, dissolution, wet chemistry, physical characterization techniques (e.g., PXRD) to generate and interpret data
Solves complex problems and devises control strategies to ensure drug substance and drug product quality
Effectively interacts with multiple functions across the organization and effectively communicates results and strategies to staff and company executives
Key contributor to and a resource for CMC sections in regulatory dossiers
Leads external relationships with contract development and manufacturing organizations (CDMO) to drive analytical activities, including method transfer, batch release, and stability studies
Manages physicochemical characterization of drug substance and related compounds
Coaches team members and establishes a high performing team environment
Overseeing analytical method development and characterization for small molecules and peptides
Other duties as assigned
Qualification
Required
BS/BA degree in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 12+ years' experience in the pharmaceutical industry, including managing pharmaceutical analytical method testing, qualification, and troubleshooting
Experience in assessing technical data to provide technical reviews of analytical data, documents, and regulatory submissions
Extensive previous managerial experience also required OR
Masters in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 10+ years of similar experience noted above OR
PhD in Analytical Chemistry, Chemistry, Pharmacy and/or related science discipline and 7+ years of similar experience noted above
Ability to oversee and manage multiple programs/projects and being more independent on daily interactions with internal functional teams and external analytical CDMOs
Proven success managing internal/external lab personnel
Expert knowledge of analytical method development, method validation, and characterization of drug substances, drug products, and related substances
Demonstrated expertise in key technologies such as HPLC/UPLC, LC-MS, GC, spectroscopy, solid state characterization, and dissolution
Strong knowledge of ICH, FDA and EMA guidance for analytical method validation, stability, CTD, and submission of analytical data
Ability to assess technical data to provide oversight of technical reviews of analytical data, documents, and regulatory submissions
Broad knowledge of formulation development for drug products with various dosage forms
Strong knowledge of cGMPs, including CMC regulatory information required for INDs/NDAs/ANDAs with respect to drug substance, pre-formulation, formulation, analytical methods, and dosage form manufacturing processes
Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
Applies in-depth knowledge of technical expertise and pharmaceutical development to solve critical issues having cross-functional impact
Ability to effectively interact with multiple functions across the organization, and effectively communicate results and strategies to staff and company executives
Strong attention to detail, excellent written and oral communication skills
Strong leadership, coaching, employee development skills
Ability to work in a cross functional team and matrix environment and influence others with or without authority at all levels of the organization
Proactive, innovative, with good problem-solving skills
Excellent written, presentation, and verbal communication skills
Preferred
Knowledge in analytical methodologies for characterizations of large molecules including peptides, proteins, and antibodies is a plus
Benefits
Annual bonus with a target of 35% 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
BioWorld Financial Watch
2026-01-16
Company data provided by crunchbase