Analytical Development Lead, Small Molecules

Neurocrine Biosciences; San Diego (CA); On-site; USD 161,000 - 220,000; Full time

Benefits offered by this job

Retirement plan

Paid vacation

Paid holidays

Paid leave (caregiver/parental)

Health benefits

Job summary

Neurocrine Biosciences is hiring an analytical development leader to drive method development, qualification, validation and transfer for small molecule programs from early development through commercialization.

You will oversee internal analytics and external CRO/CMO partnerships, guide regulatory dossier content, and develop staff to deliver high-quality scientific results within a collaborative team environment.

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.

Responsibilities

• 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.

Skills

Analytical development

Leadership

Regulatory knowledge

Problem solving

Collaboration

Education

Bachelor's in Chemistry/Pharmacy

Master's in Chemistry/Pharmacy

PhD in Chemistry/Pharmacy

Job description

Neurocrine Biosciences is hiring an analytical development leader to drive method development, qualification, validation and transfer for small molecule programs from early development through commercialization.

You will oversee internal analytics and external CRO/CMO partnerships, guide regulatory dossier content, and develop staff to deliver high-quality scientific results within a collaborative team environment.