Formulation & Process Scientist II, Pharma Development

Neurocrine Biosciences; San Diego (CA); On-site; USD 111,000 - 151,000; Full time

Benefits offered by this job

Annual bonus target 20%

Equity long-term incentive program

Retirement savings plan with company

Health benefits including medical, Rx,

Job summary

Neurocrine Biosciences is seeking a highly skilled pharmaceutical development scientist to lead CMC formulation and process development across discovery to commercial stages.

You will collaborate with Research, Chemical Development, Analytical Development, Clinical, Quality, Regulatory and CDMO partners, applying QbD and DOE principles to deliver phase-appropriate dosage forms and robust manufacturing processes. This role requires strong GMP knowledge and cross-functional leadership.

Qualifications

• Strong working knowledge of cGMP requirements across drug product development and manufacturing.
• Hands-on experience with pharmaceutical manufacturing processes development.
• Experience with regulatory submissions (IND, NDA, MAA) and drug product sections.
• Cross-functional collaboration across discovery through commercialization.

Responsibilities

• Lead formulation and process development studies to enable product advancement.
• Plan and execute DOE-based studies to optimize formulations and processes.
• Lead pilot-scale and commercial process scale-up activities.
• Prepare and maintain regulatory documentation and CMC submissions.

Skills

cGMP knowledge

Cross-functional leadership

QbD principles

DOE utilization

Analytical method knowledge

Problem solving

Communication skills

Education

BS/BA in Chemistry/related field

MS/MA in Chemistry/related field

PhD in Chemistry/related field

Tools

DOE

Statistical analysis software

Job description

Neurocrine Biosciences is seeking a highly skilled pharmaceutical development scientist to lead CMC formulation and process development across discovery to commercial stages.

You will collaborate with Research, Chemical Development, Analytical Development, Clinical, Quality, Regulatory and CDMO partners, applying QbD and DOE principles to deliver phase-appropriate dosage forms and robust manufacturing processes. This role requires strong GMP knowledge and cross-functional leadership.