Senior Scientist, CMC & Drug Product Development (Lead)

Neurocrine Biosciences, Inc.; San Diego (CA); On-site; USD 131,000 - 179,000; Full time

Benefits offered by this job

Retirement plan with company match

Paid vacation, holidays, personal days

Medical, dental, vision benefits

Equity-based long-term incentives

Job summary

Neurocrine Biosciences in San Diego seeks a Senior Technical Leader for Pharmaceutical Development, focusing on CMC across discovery to commercialization. You will provide strategic leadership in process development, characterization, and analytical strategies to enable phase-appropriate development and manufacturing readiness.

You will oversee CRO/CMO partnerships, drive DoE-based experiments, tech transfer, and collaboration across Discovery, Analytical, Regulatory, Quality, and Supply Chain

Qualifications

• Advanced knowledge of cGMP across drug product manufacturing.
• Experience authoring regulatory drug product sections (INDs, NDAs).
• Experience leading CROs/CMOs in preclinical to commercial programs.

Responsibilities

• Provide scientific and technical leadership across drug product development programs.
• Lead DoE, process modeling, scale-up, validation and tech transfer.
• Oversee external partners to ensure quality, compliance and supply.
• Partner with cross-functional teams to advance programs and knowledge transfer.

Skills

CMC leadership

Process development

DoE (experimental design)

Scale-up and validation

Technology transfer

Cross-functional leadership

Regulatory lifecycle knowledge

Analytical method validation

Quality by Design (QbD)

Education

BS/BA in Chemistry/Biochemistry/Chemical Eng

MS/MA in related field

PhD in Chemistry/Biochemistry/Chemical Eng

Job description

Neurocrine Biosciences in San Diego seeks a Senior Technical Leader for Pharmaceutical Development, focusing on CMC across discovery to commercialization. You will provide strategic leadership in process development, characterization, and analytical strategies to enable phase-appropriate development and manufacturing readiness.

You will oversee CRO/CMO partnerships, drive DoE-based experiments, tech transfer, and collaboration across Discovery, Analytical, Regulatory, Quality, and Supply Chain