Senior Principal Engineer, CMC & Tech Transfer

Neurocrine Biosciences; San Diego (CA); On-site; USD 174,000 - 237,000; Full time

Benefits offered by this job

Retirement plan

Paid vacation

Holidays and personal days

Family leave and medical leave

Health, dental, and vision benefits

Job summary

Neurocrine Biosciences seeks a senior leader to design and oversee formulation and process development across the product lifecycle, from early development to commercialization. You will manage end-to-end development, scale-up, validation, and tech transfer to CDMOs while guiding cross-functional teams and regulatory readiness.

You will provide authoritative CMC leadership, mentor junior staff, and drive lifecycle management strategies with a focus on quality, robustness, and collaboration with

Qualifications

• 10+ years in pharmaceutical industry experience in chemistry, analytical, or characterization labs.
• Experience leading formulation and process development programs from development through commercialization.
• Familiar with regulatory submissions (IND, IMPD, NDA, MAA) and lifecycle management.

Responsibilities

• Set and execute enterprise-level formulation and manufacturing strategy across the portfolio.
• Provide technical leadership within CMC from development through commercialization and lifecycle management.
• Define development strategies using QbD, DoE, modeling and statistics to ensure robust, scalable processes.
• Oversee scale-up, validation, and global tech transfer with external partners (CDMOs).
• Lead CMC subteams and communicate strategy, risks, timelines, and resources to leadership.
• Serve as SME for investigations, risk assessments, and issue resolution across development and manufacturing.
• Direct external strategy and vendor management, ensuring technical excellence and regulatory alignment.
• Provide executive oversight for CMC regulatory strategy and deliverables (IND, IMPD, NDA, MAA).
• Establish lifecycle management strategies for CPV, CPI and critical process parameters.
• Champion enabling technologies and advanced manufacturing platforms.
• Mentor scientific staff and develop leaders within the organization.

Skills

Technical leadership

CMC strategy

Regulatory readiness

Project leadership

Cross-functional collaboration

Mentoring

Process validation

External partnerships

Education

BA/BS in Chemical Engineering or related field

MS in Chemical Engineering or related field

PhD in Chemical Engineering or related field

Tools

DoE

Modeling

Statistical analysis

Process modeling

Job description

Neurocrine Biosciences seeks a senior leader to design and oversee formulation and process development across the product lifecycle, from early development to commercialization. You will manage end-to-end development, scale-up, validation, and tech transfer to CDMOs while guiding cross-functional teams and regulatory readiness.

You will provide authoritative CMC leadership, mentor junior staff, and drive lifecycle management strategies with a focus on quality, robustness, and collaboration with