Senior Engineer, Oral Solid Dose Packaging Development

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:

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

• Lead primary, secondary and tertiary packaging material selection, engineering, qualification and validation, from early clinical development through commercialization and up to product discontinuation
• Establish packaging strategies, specifications, critical material attributes, engineering and process controls, and acceptance criteria utilizing a risk-based approach
• Design, execute, interpret, and document packaging development activities, including packaging integrity, transportation studies, system qualification, and validation studies supporting product development and commercialization
• Lead technical assessments of CPO (contract packaging organization) and present site recommendations to leadership
• Drive packaging site readiness for clinical trial and commercial production, including line trials, process qualification & validation, and technology transfer
• Lead technical investigations for packaging and distribution related deviations/nonconformances
• Lead the implementation of technical changes on approved products in partnership with Packaging Operations
• Lead packaging artwork development, including dielines, product requirements, specifications, barcodes, and packaging line compatibility
• Lead product level technical assessments for serialization requirements and changes in partnership with internal and external functions
• Author and review sections of regulatory submissions and responses to health authority inquiries related to packaging systems
• Remain abreast of market trends and emerging technologies in the packaging space
• Other duties as assigned

Requirements:

• Bachelor's Degree in Packaging, Mechanical, or Materials Engineering or related field and 6+ years of experience in the pharmaceutical development, or technical operations and product quality OR
• Master's Degree in Packaging, Mechanical, or Materials Engineering or related field and 4+ years of experience as shown above OR
• PhD and 2+ years of experience as shown above
• In-depth knowledge of pharmaceutical packaging development across one or more dosage-form, including oral packaging and/or parenteral packaging. Individual positions may be aligned to one or more modalities based on business need
• Direct and proven experience in primary, secondary and tertiary pharmaceutical packaging engineering across relevant dosage forms and packaging configurations
• Demonstrated success collaborating cross-functionally with internal and external functions
• Knowledge of applicable global regulatory, pharmacopeial, and industry standards and guidance, with the ability to translate these expectations into packaging system requirements, component specifications, acceptance criteria, and qualification and validation strategies
• Experience working in a cGMP-regulated environment, including knowledge of relevant US and Ex-US regulatory and quality requirements, compendial expectations, European Good Distribution Practices (GDP), and state-of-the-art standards and practices pertaining to primary, secondary, and tertiary packaging
• Experience supporting packaging activities across clinical development, registration, commercial launch, and lifecycle management, including qualification or validation, investigations, change control, technology transfer, and packaging site readiness
• Working knowledge of project management methodologies
• Working knowledge of packaging equipment, line trials, transportation qualification, and cold-chain requirements, as applicable to the assigned role

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Neurocrine 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.

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