Associate Director, Analytical Development (Small Molecule)

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

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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

#LI-LS1

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

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