Associate Engineering Director, Combination Drug Product/Device
Neurocrine Biosciences
August 14, 2026
Remote friendly (San Diego, CA)
United States
Operations
About the Role
In partnership with the 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. Provides technical ownership for delivery devices and associated primary and secondary packaging from early development through commercialization and post-approval lifecycle management.
Your Contributions
- 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 delivery device solutions (prefilled syringe, autoinjector, and other injectable platforms)
- Serve as device/combination product subject matter expert on cross-functional CMC and program teams
- Lead technical decision-making, risk management, and issue resolution for 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 meet global regulatory, cGMP, safety, and quality expectations
- Identify, evaluate, engage, and manage external partners for device development, manufacturing, testing, and commercialization
- Monitor innovation and industry trends in injectable delivery systems
- Support integration of delivery device and drug product strategies across modalities (peptides, proteins, antibodies, gene therapy)
Requirements
- BS/BA (10+ years) OR MS/MA (8+ years) OR PhD (5+ years) in Mechanical or Biomedical Engineering or related field
- Essential experience developing and commercializing drug/device combination products (e.g., pre-filled syringes, autoinjectors)
- Advanced knowledge of design controls, verification/validation, risk management, design transfer, and lifecycle management
- Experience with manufacturing scale-up, technology transfer, and external partner/supplier oversight
- Thorough understanding of cGMP, quality systems, and global regulatory expectations (FDA, EMA, applicable ISO standards)
- Knowledge of drug delivery technologies, connected health solutions, human factors/usability, and emerging injectable trends
- Ability to solve complex technical challenges and influence cross-functional teams
- Strong communication, collaboration, and leadership in a matrixed environment
Preferred Qualifications
- Experience with regulatory filings, health authority interactions, or commercial launch readiness
- Experience with device developers, contract manufacturers, testing labs, or component suppliers
- Familiarity with primary container closure systems, secondary packaging, human factors engineering, and constituent part control strategies
- Experience across multiple modalities (peptides, proteins, antibodies, gene therapy)
In partnership with the 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. Provides technical ownership for delivery devices and associated primary and secondary packaging from early development through commercialization and post-approval lifecycle management.
Your Contributions
- 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 delivery device solutions (prefilled syringe, autoinjector, and other injectable platforms)
- Serve as device/combination product subject matter expert on cross-functional CMC and program teams
- Lead technical decision-making, risk management, and issue resolution for 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 meet global regulatory, cGMP, safety, and quality expectations
- Identify, evaluate, engage, and manage external partners for device development, manufacturing, testing, and commercialization
- Monitor innovation and industry trends in injectable delivery systems
- Support integration of delivery device and drug product strategies across modalities (peptides, proteins, antibodies, gene therapy)
Requirements
- BS/BA (10+ years) OR MS/MA (8+ years) OR PhD (5+ years) in Mechanical or Biomedical Engineering or related field
- Essential experience developing and commercializing drug/device combination products (e.g., pre-filled syringes, autoinjectors)
- Advanced knowledge of design controls, verification/validation, risk management, design transfer, and lifecycle management
- Experience with manufacturing scale-up, technology transfer, and external partner/supplier oversight
- Thorough understanding of cGMP, quality systems, and global regulatory expectations (FDA, EMA, applicable ISO standards)
- Knowledge of drug delivery technologies, connected health solutions, human factors/usability, and emerging injectable trends
- Ability to solve complex technical challenges and influence cross-functional teams
- Strong communication, collaboration, and leadership in a matrixed environment
Preferred Qualifications
- Experience with regulatory filings, health authority interactions, or commercial launch readiness
- Experience with device developers, contract manufacturers, testing labs, or component suppliers
- Familiarity with primary container closure systems, secondary packaging, human factors engineering, and constituent part control strategies
- Experience across multiple modalities (peptides, proteins, antibodies, gene therapy)