GMP Lab Analytical Development Leader

Neurocrine Biosciences; San Diego (CA); On-site; USD 144,000 - 196,000; Full time

Benefits offered by this job

Health benefits

Retirement savings plan (company match

Paid vacation and holidays

Equity-based long-term incentive

Job summary

Neurocrine Biosciences in San Diego, CA seeks a senior analytical leader to oversee development and GMP laboratory operations from preclinical to commercialization, ensuring high-quality analytical execution and regulatory readiness.

You will lead cross-functional teams, establish SOPs, manage instrument qualification, support audits, and drive continuous improvement while partnering with external contractors to advance CMC objectives.

Qualifications

• Bachelor’s degree and 8+ years of analytical pharma experience, or Master’s with 6+ years, or PhD with 4+ years.
• Working knowledge of cGMP, GLP and GDP.
• Expert in at least one analytical discipline and data review.
• Experience in method validation/transfer and regulatory submissions.

Responsibilities

• Lead analytical development and GMP lab activities from preclinical to commercialization.
• Oversee staffing, budgeting, SOPs and instrument qualification for data integrity.
• Drive audits, inspections readiness, and cross-functional collaboration on CMC plans.
• Mentor and develop laboratory personnel and manage external contractor activities.
• Represent analytical development on cross-functional teams.

Skills

cGMP

GLP

Analytical method validation

FDA guidance

ICH guidance

Leadership

Project management

Data review

Education

Bachelor's degree in Chemistry or life science

Master's degree in Chemistry or life science

PhD in Chemistry or life science

Job description

Neurocrine Biosciences in San Diego, CA seeks a senior analytical leader to oversee development and GMP laboratory operations from preclinical to commercialization, ensuring high-quality analytical execution and regulatory readiness.

You will lead cross-functional teams, establish SOPs, manage instrument qualification, support audits, and drive continuous improvement while partnering with external contractors to advance CMC objectives.