Senior Engineer, Oral Solid Dose Packaging Development

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 , and follow the company on Linked In, X, Facebook and You Tube. (
* in collaboration with Abb Vie)

About the Role:

The Senior Engineer, Oral Solid Dose Packaging Development provides technical leadership for packaging systems supporting assigned products from early clinical development through commercialization and lifecycle management. The role leads primary packaging engineering & development, packaging material selection, container closure system development, secondary and tertiary packaging. This position partners with Clinical Supply Chain, Packaging Operations, Pharmaceutical Development, Quality, Regulatory Affairs, Supply Chain, external manufacturing sites, testing laboratories, and packaging vendors.

• Lead end-to-end packaging material selection, engineering, and qualification for oral solid dose container closure systems and associated secondary and tertiary packaging, from early clinical development through commercialization and lifecycle management
• Establish packaging strategies, specifications, critical material attributes, engineering and process controls, and acceptance criteria based on product, stability, patient, packaging, and regulatory requirements
• Design, execute, interpret, and document packaging development, package integrity, transportation, qualification, and validation studies supporting clinical trial materials and registration stability
• Lead technical assessments for CPO (contract packaging organization) selection and drive packaging site readiness for commercial launch, including line trials, packaging qualification, process validation, technology transfer, launch execution, and operational handover
• Lead technical investigations for packaging related deviations, and nonconformances, and retain post launch technical ownership for lifecycle changes, troubleshooting, packaging vendors and CPO transfers, and continuous improvement in partnership with Packaging Operations
• Lead packaging artwork development, including dielines, component specifications, print requirements, barcodes, serialization product requirements, and packaging line compatibility
• Author and review regulatory packaging content, including container closure system information, packaging development data, technical justifications, and responses to health authority questions
• Partner with internal teams and external organizations to deliver packaging programs and evaluate emerging materials, technologies, and sustainability solutions

• Bachelor’s degree in Packaging Science, Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related technical field with 4+ years of relevant experience; or Master’s degree with typically 2+ years of applicable experience
• Experience in pharmaceutical packaging development or packaging engineering within a cGMP-regulated environment, with working knowledge of applicable FDA and ICH guidance, USP requirements, and ASTM, ISTA, and ISO standards
• Direct experience with oral solid dose packaging, including bottle and/or blister…