Sr. Principal Engineer, 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

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

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.

Your Contributions:

• 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

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 #LI-DM1

EEO Statement:

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements.

Compensation & Benefits:

The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program.

• a 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 in accordance with the terms and conditions of the applicable plans.

We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2025. We were also named a Great Place to Work company.

2025 Fortune Media IP Limited. All rights reserved. Used under license.

Our Values:

• PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
• INNOVATION: We seek and create optimal solutions.
• TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!