Senior Engineer, Oral Solid Dose Packaging Development

Neurocrine Biosciences • San Diego, CA

6d

About The Position

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.

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

Nice To Haves

• 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 line qualification
• Experience developing or qualifying parenteral packaging and container closure systems, including vials, stoppers, prefilled syringes, cartridges, or other injectable product configurations
• Experience developing packaging strategies for moisture-sensitive products, including desiccant systems, high-barrier blister materials, induction sealing, and moisture-protection studies
• Experience with child-resistant, senior-friendly, tamper-evident, or patient-centered packaging systems
• Experience leading packaging technology transfers, CPO site readiness, alternate vendor qualifications, or commercial packaging site transfers

Responsibilities

• 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

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior