Senior Engineer, Oral Solid Dose Packaging Development

Senior Engineer, Oral Solid Dose Packaging DevelopmentNeurocrine 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 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 managementEstablish packaging strategies, specifications, critical material attributes, engineering and process controls, and acceptance criteria based on product, stability, patient, packaging, and regulatory requirementsDesign, execute, interpret, and document packaging development, package integrity, transportation, qualification, and validation studies supporting clinical trial materials and registration stabilityLead 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 handoverLead 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 OperationsLead packaging artwork development, including dielines, component specifications, print requirements, barcodes, serialization product requirements, and packaging line compatibilityAuthor and review regulatory packaging content, including container closure system information, packaging development data, technical justifications, and responses to health authority questionsPartner with internal teams and external organizations to deliver packaging programs and evaluate emerging materials, technologies, and sustainability solutionsRequirements: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 experienceExperience 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 standardsDirect experience with oral solid dose packaging, including bottle and/or blister packaging systemsExperience 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 variabilityExperience supporting packaging activities across development and commercial phases, including clinical trial materials, registration stability, regulatory submissions, commercial launch, and lifecycle managementExperience authoring and reviewing packaging content for regulatory submissions, including container closure system information, packaging development data, technical justifications, and responses to health authority questionsExperience planning and executing packaging development, package integrity, transportation, qualification, and validation studies, engineering and process controls, and acceptance criteriaExperience supporting packaging equipment, line trials, technical site assessments, process validation, technical site transfer, packaging related investigations, change controls, and CAPAStrong technical judgment, problem-solving, project management, communication, and cross-functional leadership skillsPreferred Requirements:Six or more years of pharmaceutical packaging development or packaging engineering experience, with demonstrated technical leadership for oral solid dose productsExperience independently leading packaging programs from early clinical development through registration, commercial launch, and post-approval lifecycle managementExperience with sachet, stick-pack, or flexible-laminate packaging, including material selection, seal development, package integrity, equipment compatibility, and line qualificationExperience developing or qualifying parenteral packaging and container closure systems, including vials, stoppers, prefilled syringes, cartridges, or other injectable product configurationsExperience developing packaging strategies for moisture-sensitive products, including desiccant systems, high-barrier blister materials, induction sealing, and moisture-protection studiesExperience with child-resistant, senior-friendly, tamper-evident, or patient-centered packaging systemsExperience leading packaging technology transfers, CPO site readiness, alternate vendor qualifications, or commercial packaging site transfersNeurocrine 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. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. 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 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.