Associate Director, Analytical Development (Small Molecule)
Neurocrine Biosciences
Summary
Provides scientific and people leadership for an area within Analytical Development (AD) and Technical Operations (Tech Ops), focused on small molecule pharmaceuticals. Leads a sub-team in analytical development and/or serve as a CMC / analytical lead for multiple projects to guide internal and external analytical activities including method development, qualification, validation, transfer, control strategies, stability studies, and CMC submissions supporting drug substance and drug product development from early development through commercialization. Translates departmental strategy into operational plans, provides technical guidance, and develops scientific staff to support successful program execution.
Job description
About the Role
Provides scientific and people leadership for an area within Analytical Development (AD) and Technical Operations (Tech Ops), focused on small molecule pharmaceuticals. Leads a sub-team in analytical development and/or serve as a CMC / analytical lead for multiple projects to guide internal and external analytical activities including method development, qualification, validation, transfer, control strategies, stability studies, and CMC submissions supporting drug substance and drug product development from early development through commercialization. Translates departmental strategy into operational plans, provides technical guidance, and develops scientific staff to support successful program execution.
Your Contributions (include, but are not limited to)
- Recommends scientific and operational direction for assigned area and translates departmental strategy into tactical plans and team objectives.
- Leads analytical development activities across assigned programs/projects, including method development, qualification, validation, transfer, stability, and characterization.
- Provides technical leadership and recommends solutions to complex analytical development challenges.
- Oversees internal analytical activities and external CMO/CRO partnerships to support program timelines and deliverables.
- Partners with colleagues on the design, development, validation, and transfer of analytical methods for drug products.
- Contributes technical expertise to CMC regulatory dossiers and supports preparation and review of analytical sections for regulatory submissions.
- Evaluates analytical data, technical reports, and regulatory documentation to ensure scientific quality and compliance.
- Supports resource planning and prioritization for assigned activities in alignment with departmental objectives.
- Coaches and develops scientific staff and promotes a collaborative, accountable, and high-performing team environment.
- Other duties as assigned.
Common Knowledge & Skills
- Emerging internal scientific thought leader with strong technical expertise in analytical development.
- Applies in-depth scientific knowledge and critical thinking to resolve complex analytical development problems.
- Ability to translate established strategy and priorities into operational and tactical plans.
- Strong leadership, coaching, employee development, and influencing skills.
- Excellent written, verbal, presentation, problem-solving, and analytical skills.
- Ability to collaborate effectively across functions and within a matrix environment.
- Demonstrated ability to manage multiple projects, priorities, and external relationships.
- Learning agility and willingness to evaluate innovative scientific approaches and technologies.
Job-Specific Knowledge & Qualifications
- Strong knowledge of analytical method development, qualification, validation, transfer, and troubleshooting.
- Strong knowledge of ICH and FDA guidance related to analytical methods, stability, CTD, and CMC regulatory submissions.
- Experience evaluating analytical data, technical documents, and regulatory submissions.
- Knowledge of cGMP requirements and CMC regulatory expectations supporting drug substance and drug product development.
- Experience managing analytical activities with external CROs/CMOs.
- Knowledge of physicochemical characterization of APIs, drug substances, drug products, and related compounds.
- Understanding of formulation and process development and their relationship to analytical development.
- Previous people leadership and/or demonstrated leadership of scientific teams, projects, or external partners required.
Requirements
- Bachelors degree in Chemistry, Pharmacy, or related scientific discipline AND 10+ years of applicable pharmaceutical industry experience OR Master's degree in Chemistry, Pharmacy, or related scientific discipline AND 8+ years of applicable pharmaceutical industry experience OR PhD in Chemistry, Pharmacy, or related scientific discipline AND 6+ years of applicable experience
- Strong knowledge of analytical method development, qualification, validation, transfer, and troubleshooting
- Strong knowledge of ICH and FDA guidance related to analytical methods, stability, CTD, and CMC regulatory submissions
- Experience evaluating analytical data, technical documents, and regulatory submissions
- Knowledge of cGMP requirements and CMC regulatory expectations supporting drug substance and drug product development
- Experience managing analytical activities with external CROs/CMOs
- Knowledge of physicochemical characterization of APIs, drug substances, drug products, and related compounds
- Understanding of formulation and process development and their relationship to analytical development
- Previous people leadership and/or demonstrated leadership of scientific teams, projects, or external partners required
- Emerging internal scientific thought leader with strong technical expertise in analytical development
- Applies in-depth scientific knowledge and critical thinking to resolve complex analytical development problems
- Ability to translate established strategy and priorities into operational and tactical plans
- Strong leadership, coaching, employee development, and influencing skills
- Excellent written, verbal, presentation, problem-solving, and analytical skills
- Ability to collaborate effectively across functions and within a matrix environment
- Demonstrated ability to manage multiple projects, priorities, and external relationships
- Learning agility and willingness to evaluate innovative scientific approaches and technologies
Benefits
- 401(k) Matching
- Paid Vacation
- Paid Holidays
- Paid Personal Days
- Paid Caregiver Leave
- Paid Parental Leave
- Paid Medical Leave
- Medical, Dental & Vision
- Prescription Drug Coverage
- Annual Bonus
- Equity Incentive Program
Company overview
Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company founded in 1992 and headquartered in San Diego, California. The company specializes in discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Neurocrine's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis, and uterine fibroids. Their flagship product, INGREZZA (valbenazine), was the first FDA-approved treatment for adults with tardive dyskinesia. The company maintains a robust pipeline with multiple compounds in mid- to late-phase clinical development across core therapeutic areas, including Parkinson's disease, Tourette syndrome, and major depressive disorder. Neurocrine operates with a purpose to relieve suffering for people with great needs, applying unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions. The company is publicly traded on NASDAQ under the symbol NBIX and has established strategic collaborations with major pharmaceutical partners including AbbVie.