Associate Engineering Director, Combination Drug Product/Device

About the role

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 patients with 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 ) In partnership with the broader CMC organization, the Associate Director of Drug/Device Combination Products will lead the development and lifecycle strategy for drug/device combination products, including prefilled syringe and autoinjector presentations. This role will provide technical ownership for delivery devices and associated primary and secondary packaging from early development through commercialization and post approval lifecycle management. The successful candidate will serve as a subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration. This individual will work closely with cross-functional partners across CMC, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and external development and manufacturing partners to advance a pipeline of injectable products. _ Your Contributions (include, but are not limited to): Lead strategic planning and execution of drug/device combination product development for clinical and commercial presentations Provide technical ownership for delivery devices, primary packaging, and related combination product elements across the product lifecycle Develop and implement innovative delivery device solutions, including prefilled syringe, autoinjector, and other injectable delivery platforms Serve as the device and combination product subject matter expert on cross-functional CMC and program teams Lead technical decision-making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management Ensure timely completion of development, verification, validation, manufacturing, and technology transfer deliverables Partner with Quality, Regulatory, and external suppliers to ensure combination product strategies meet global regulatory, cGMP, safety, and quality expectations Identify, evaluate, engage, and manage external partners for device development, manufacturing, testing, and commercialization activities Monitor external innovation, emerging technologies, connected health solutions, and industry trends in injectable delivery systems Support integration of delivery device and drug product strategies across multiple therapeutic modalities, including peptides, proteins, antibodies, and gene therapy products