Sr. Principal Engineer, Tech Transfer

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

Job summary

Neurocrine Biosciences is seeking a senior leader to direct formulation and process development across the product lifecycle. You will manage end-to-end development, scale-up, validation, and technology transfer to ensure robust, compliant drug products for clinical and commercial supply.

You will mentor junior staff and drive cross-functional collaboration with regulatory and clinical teams. The role emphasizes strategic CMC leadership, applying DoE, QbD, and modeling to establish scalable,

Qualifications

• Requires strong leadership in CMC and formulation
• Experience guiding development from early to commercialization
• Mentor junior team members and lead cross-functional subteams

Responsibilities

• Set enterprise-level strategy for drug product formulation and manufacturing
• Provide technical leadership within CMC from early development through lifecycle
• Define development strategies using QbD, DoE, modeling
• Oversee process development, scale-up, validation, and tech transfer
• Lead CMC subteams and align with cross-functional teams

Skills

Leadership

Cross-functional

Process development

Education

BA/BS in Chemical Engineering or Pharmaceutical Sciences

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 (include, but are not limited to):

• 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

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 OR Maste