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San Diego, California, United States
Onsite
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)
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Lead strategic planning and execution of drug/device combination product development for clinical and commercial presentations
Provide technical ownership for delivery devices, primary packaging, and related combination product elements across the product lifecycle
Develop and implement innovative delivery device solutions, including prefilled syringe, autoinjector, and other injectable delivery platforms
Serve as the device and combination product subject matter expert on cross-functional CMC and program teams
Lead technical decision-making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management
Ensure timely completion of development, verification, validation, manufacturing, and technology transfer deliverables
Partner with Quality, Regulatory, and external suppliers to ensure combination product strategies meet global regulatory, cGMP, safety, and quality expectations
Identify, evaluate, engage, and manage external partners for device development, manufacturing, testing, and commercialization activities
Monitor external innovation, emerging technologies, connected health solutions, and industry trends in injectable delivery systems
Support integration of delivery device and drug product strategies across multiple therapeutic modalities, including peptides, proteins, antibodies, and gene therapy products
BS/BA in Mechanical Engineering, Biomedical Engineering, or a related field, with 10+ years of industry experience, OR
MS/MA in Mechanical Engineering, Biomedical Engineering, or a related field, with 8+ years of industry experience, OR
PhD in Mechanical Engineering, Biomedical Engineering, or a related field, with 5+ years of industry experience
Experience developing and commercializing drug/device combination products (e.g., pre-filled syringe systems, autoinjectors) is essential
Advanced knowledge of design controls, design verification and validation, risk management, design transfer, and lifecycle management
Experience with manufacturing scale-up, technology transfer, and external partner or supplier oversight
Thorough understanding of cGMP, quality systems, and global regulatory expectations for combination products and medical devices, including FDA, EMA, and applicable ISO standards
Current knowledge of drug delivery technologies, connected health solutions, human factors/usability engineering, and emerging trends in injectable product development
Proven ability to solve complex technical challenges, make sound risk-based decisions, and influence cross-functional teams
Strong communication, collaboration, and leadership skills in a matrixed environment
Preferred Qualifications
Experience supporting regulatory filings, health authority interactions, or commercial launch readiness for combination products
Experience working with external device developers, contract manufacturers, testing laboratories, or component suppliers
Familiarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategies
Experience supporting products across multiple modalities, including peptides, proteins, antibodies, or gene therapy products
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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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The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00. 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 30% 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.