Senior Scientist, CMC & Pharmaceutical Development

neurocrine; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Neurocrine Biosciences is seeking a senior technical leader to oversee CMC across the product lifecycle, from discovery to commercialization. Lead development programs, design robust formulations, and ensure regulatory alignment with global agencies.

You will manage CRO/CMO partnerships, guide tech transfer, and drive process improvement to enable phase-appropriate development and manufacturing readiness.

Qualifications

• BS/BA in Chemistry, Biochemistry, Chemical Engineering or related field with 6+ years pharma industry experience.
• MS/MA with 4+ years or PhD with 2+ years in chemistry/analytical labs.
• Solid understanding of cGMP across drug product manufacturing and regulatory expectations.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Provide scientific and technical leadership across drug product development programs from early discovery through commercial launch.
• Lead project team meetings and communicate progress, risks, resources, and timelines.
• Design, develop, and scale formulations and manufacturing processes using QbD principles.
• Lead DoE, process modeling, scale-up, validation, and technology transfer to internal and external manufacturing sites.
• Serve as SME to investigate and resolve complex technical issues across preformulation, formulation, analytical, and manufacturing activities.
• Oversee collaborations with CDMOs and vendors to ensure quality and supply of materials.
• Act as technical lead during manufacturing campaigns and on-site activities.
• Collaborate cross-functionally to advance programs and knowledge transfer across development stages.
• Lead or support CMC strategy and regulatory submissions (IND, IMPD, NDA, MAA).
• Drive CPV and CPI via data analysis of CPPs and CQAs.

Skills

CMC Leadership

Process Development

QbD Principles

Scale-up & Tech Transfer

Analytical Strategy

Regulatory Submissions

Education

BS in Chemistry/Biochemistry/Chemical Engineering

MS in Chemistry/Biochemistry/Chemical Engineering

PhD in Chemistry/Biochemistry/Chemical Engineering

Job description

Neurocrine Biosciences is seeking a senior technical leader to oversee CMC across the product lifecycle, from discovery to commercialization. Lead development programs, design robust formulations, and ensure regulatory alignment with global agencies.

You will manage CRO/CMO partnerships, guide tech transfer, and drive process improvement to enable phase-appropriate development and manufacturing readiness.