Senior Engineer, Oral Solid Dose Packaging – Lead & Launch

Neurocrine Biosciences; San Diego (CA); Vor Ort; USD 97.000 - 133.000; Vollzeit

Benefits dieser Stelle

Retirement savings plan

Paid vacation

Health benefits

Zusammenfassung

Neurocrine Biosciences in San Diego seeks a Senior Engineer for Oral Solid Dose Packaging Development to lead end‑to‑end packaging engineering, material selection, and container closure systems through clinical to lifecycle management.

The role requires strong regulatory packaging knowledge and cross‑functional leadership to drive packaging strategies, qualification, and technology transfer with internal teams and vendors.

Qualifikationen

• Bachelor’s degree in Packaging Science, Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field with 4+ years of experience.
• Experience in pharmaceutical packaging development in a cGMP environment and knowledge of FDA/ICH guidelines, USP, ASTM/ISO standards.
• Direct experience with oral solid dose packaging, including bottles or blister systems.
• Experience selecting and qualifying packaging materials and container closure systems with moisture/oxygen barrier, light protection, and aging considerations.
• Experience across development and commercial phases, including regulatory submissions and lifecycle management.

Aufgaben

• Lead end-to-end packaging material selection, engineering, and qualification for oral solid dose systems through lifecycle management.
• Establish packaging strategies, specifications, and acceptance criteria based on product and regulatory requirements.
• Design and document packaging development, package integrity, transport studies, and validation for clinical and registration materials.
• Lead technical assessments for CPO selection and prepare sites for commercial launches, including line trials and technology transfer.
• Lead investigations for packaging deviations and manage post-launch ownership and improvements with vendors.
• Develop packaging artwork, dielines, print requirements, barcodes, and serialization compliance.
• Prepare regulatory submissions content related to container closure systems and packaging data.

Kenntnisse

Packaging engineering

Material selection

Container closure systems

Regulatory packaging knowledge

Cross-functional leadership

Ausbildung

Bachelor's degree in Packaging Science/Engineering etc.

Jobbeschreibung

Neurocrine Biosciences in San Diego seeks a Senior Engineer for Oral Solid Dose Packaging Development to lead end‑to‑end packaging engineering, material selection, and container closure systems through clinical to lifecycle management.

The role requires strong regulatory packaging knowledge and cross‑functional leadership to drive packaging strategies, qualification, and technology transfer with internal teams and vendors.