Neurocrine
Associate Engineering Director, Combination Drug Product/Device
US CA San Diego · Director
Sponsorship not specified$174k-$237kDetected 7 days ago
Product ManagementSupply ChainMechanical DesignGMPFDA RegulatoryCRISPRMedical DevicesLeadershipCommunicationCollaborationPublic Speaking
About the role
- This role will provide technical ownership for delivery devices and associated primary and secondary packaging from early development through commercialization and post approval lifecycle management.
- Your Contributions (include, but are not limited to):
- Provide technical ownership for delivery devices, primary packaging, and related combination product elements across the product lifecycle
Responsibilities
- The successful candidate will serve as a subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration.
- Develop and implement innovative delivery device solutions, including prefilled syringe, autoinjector, and other injectable delivery platforms
- 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
- Support integration of delivery device and drug product strategies across multiple therapeutic modalities, including peptides, proteins, antibodies, and gene therapy products
- Lead strategic planning and execution of drug/device combination product development for clinical and commercial presentations
- Lead technical decision-making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management
Requirements
- 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 with drug/device integration, manufacturing scale-up, technology transfer, and external partner or supplier oversight
- Proven ability to solve complex technical challenges, make sound risk-based decisions, and influence cross-functional teams
Nice to have
- 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
Compensation
- The annual base salary we reasonably expect to pay is $173,600.00-$237,000.00.
Benefits
- Monitor external innovation, emerging technologies, connected health solutions, and industry trends in injectable delivery systems
Company info
- 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 patients with 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:
- In partnership with the broader CMC organization, the Associate Director of Drug/Device Combination Products will lead the development and lifecycle strategy for drug/device combination products, including prefilled syringe and autoinjector presentations. This role will provide technical ownership for delivery devices and associated primary and secondary packaging from early development through commercialization and post approval lifecycle management.
- The successful candidate will serve as a subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration. This individual will work closely with cross-functional partners across CMC, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and external development and manufacturing partners to advance a pipeline of injectable products. _
- 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 patients with 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 )
- to relieve suffering for people with great needs.
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