Sr. Principal Engineer, Tech Transfer

Neurocrine Biosciences • San Diego, CA

2d • $173,600 - $237,000

About The Position

Leads the design and execution of formulation and process development activities across the product lifecycle, supporting programs from early development through commercialization and delivering phase-appropriate drug products aligned with target product profiles. Manages end-to-end development activities, including formulation screening, scale-up, process optimization, validation, and technology transfer to CDMOs, while supporting external partnerships for clinical and commercial supply. Contributes technical leadership within CMC teams, collaborating cross-functionally to advance programs, support regulatory readiness, and drive continuous improvement, while mentoring junior team members and supporting robust process and product control strategies.

Requirements

• BA/BS degree in Chemical Engineering, Pharmaceutical Sciences, or other Life Sciences related field AND 10+ years of pharmaceutical industry experience, specifically in a chemistry, analytical, or characterization laboratory setting
• Master's degree in Chemical Engineering, Pharmaceutical Sciences, or other Life Sciences related field AND 8+ years of similar experience noted above
• PhD in Chemical Engineering, Pharmaceutical Sciences, or other Life Sciences related field AND 6+ years of similar experience noted above, may include post doc experience

Responsibilities

• Set and drive enterprise-level strategy for drug product formulation and manufacturing across the portfolio, ensuring alignment with corporate objectives, regulatory expectations, and long-term commercial success
• Provide authoritative technical leadership within CMC, guiding program direction from early development through commercialization and lifecycle management, and influencing key decisions at the project and portfolio level
• Define and govern development strategies for formulations and manufacturing processes, applying advanced scientific principles (e.g., QbD, DoE, modeling, and statistical approaches) to establish robust, scalable, and well-controlled processes
• Oversee and ensure successful execution of process development, scale-up, validation, and global technology transfer activities, resolving complex technical and operational challenges to enable reliable clinical and commercial supply
• Lead CMC subteams and influence cross-functional teams, ensuring clear communication of program strategy, risks, timelines, and resource needs to senior leadership and stakeholders
• Serve as a recognized subject matter expert, providing strategic oversight and direction for complex investigations, risk assessments, and issue resolution across development and manufacturing
• Direct external strategy and partnerships, including selection, oversight, and performance management of CDMOs and vendors, ensuring technical excellence, compliance, and alignment with program and portfolio needs
• Provide executive-level oversight and final accountability for CMC regulatory strategy and deliverables (e.g., IND, IMPD, NDA, MAA), ensuring high-quality submissions and successful global regulatory interactions
• Establish and drive lifecycle management strategies, including CPV, CPI, and proactive risk management for critical process parameters and quality attributes, ensuring sustained product performance and compliance
• Champion innovation by identifying, prioritizing, and implementing enabling technologies, advanced manufacturing approaches, and platform capabilities to strengthen organizational effectiveness and competitive advantage
• Lead knowledge management and standard-setting initiatives, fostering best practices, data integrity, and organizational learning across programs and teams
• Mentor and develop scientific staff and emerging leaders, shaping technical capabilities within the organization and serving as a trusted advisor to senior leadership on development strategy, risk, and portfolio prioritization
• Represent the organization externally in regulatory interactions, industry forums, and scientific engagements, influencing technical positioning and enhancing the company’s reputation
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Principal