Senior Engineer, Oral Solid Dose Packaging Development
Neurocrine Biosciences · San Diego
CMCFull-time$97k–$133kCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
What they're looking for
- Bachelor's degree in packaging science, engineering, materials science, or related technical field with 4+ years experience; or Master's degree with 2+ years experience
- Pharmaceutical packaging development experience in cGMP-regulated environment with FDA, ICH, USP, ASTM, ISTA, ISO standards knowledge
- Direct experience with oral solid dose bottle and/or blister packaging systems
- Expertise selecting, developing, qualifying packaging materials and container closure systems; knowledge of barrier properties, compatibility, mechanical performance
- Experience authoring regulatory packaging submissions including container closure system information and health authority responses
- Planning and executing packaging development, integrity, transportation, qualification, and validation studies
- Strong technical judgment, problem-solving, project management, and cross-functional leadership capabilities
What you'll be doing
- Lead end-to-end packaging material selection, engineering, and qualification from clinical development through commercialization and lifecycle management
- Establish packaging strategies, specifications, critical attributes, engineering controls, and acceptance criteria based on product and regulatory requirements
- Design, execute, interpret, and document packaging development and validation studies supporting clinical trials and registration stability
- Lead contract packaging organization selection and drive site readiness for commercial launch including line trials and technology transfer
- Lead packaging-related investigations, post-launch technical ownership for lifecycle changes, vendor management, and continuous improvement initiatives
Privacy & handoff
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