Senior Engineer, Oral Solid Dose Packaging Development

About this role

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: 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. _ Your Contributions (include, but are not limited to): • 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

Requirements: • 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 packaging systems

• Experience selecting, developing, and qualifying packaging materials, primary packaging components, and container closure systems, with knowledge of moisture and oxygen barrier properties, light protection, compatibility, mechanical performance, aging, and material variability

• Experience supporting packaging activities across development and commercial phases, including clinical trial materials, registration stability, regulatory submissions, commercial launch, and lifecycle management

• Experience authoring and reviewing packaging content for regulatory submissions, including container closure system information, packaging development data, technical justifications, and responses to health authority questions

• Experience planning and executing packaging development, package integrity, transportation, qualification, and validation studies, engineering and process controls, and acceptance criteria

• Experience supporting packaging equipment, line trials, technical site assessments, process validation, technical site transfer, packaging related investigations, change controls, and CAPA

• Strong technical judgment, problem-solving, project management, communication, and cross-functional leadership skills

Preferred Requirements: • Six or more years of pharmaceutical packaging development or packaging engineering experience, with demonstrated technical leadership for oral solid dose products

• Experience independently leading packaging programs from early clinical development through registration, commercial launch, and post-approval lifecycle management

• Experience with sachet, stick-pack, or flexible-laminate packaging, including material selection, seal development, package integrity, equipment compatibility, and

Similar jobs

• Senior Specialist, Engineering - Oral Solid Dose Packaging — Merck · Wilson, North Carolina, United States
• Senior Process Engineer, Oral Solid Dosage — Biibhr · Research Triangle Park, NC
• Senior Packaging Engineer, Pharmaceutical Development — Elanco · Indianapolis, IN
• Engineer, Packaging Development — Mars · USA-Tennessee-Franklin
• Senior Engineer, Semi Packaging Engineering — Analog Devices · CA, San Jose, Rio Robles
• Principal Engineer - Packaging Equipment — Conagra Brands (Careers US) · Remote
• Senior Engineer, Semiconductor Packaging — Analog Devices · Wilmington, MA
• Senior Packaging Engineer — Every day Chemours · Wilmington (Headquarters), DE