Associate Engineering Director, Combination Drug Product/Device
Neurocrine Biosciences
July 02, 2026
Remote friendly (San Diego, CA)
United States
Operations
About The Role
- Lead development and lifecycle strategy for drug/device combination products (including prefilled syringe and autoinjector presentations).
- Provide technical ownership for delivery devices and associated primary/secondary packaging from early development through commercialization and post-approval lifecycle management.
- Serve as subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration.
- Partner cross-functionally across CMC, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and external partners to advance an injectable product pipeline.
Your Contributions (include, But Are Not Limited To)
- Lead strategic planning/execution for clinical and commercial combination product development.
- Own delivery devices and primary packaging/combination product elements across the product lifecycle.
- Develop innovative delivery device solutions (prefilled syringe, autoinjector, and other injectable platforms).
- Lead technical decision-making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management.
- Ensure timely completion of development, V&V, manufacturing, and technology transfer deliverables.
- Partner with Quality, Regulatory, and external suppliers to meet global regulatory, cGMP, safety, and quality expectations.
- Identify, manage, and oversee external partners for device development, manufacturing, testing, and commercialization.
- Monitor emerging technologies and industry trends in injectable delivery systems.
- Support integration of delivery device and drug strategies across modalities (peptides, proteins, antibodies, gene therapy).
Requirements
- BS/BA (10+ yrs) or MS/MA (8+ yrs) or PhD (5+ yrs) in Mechanical Engineering, Biomedical Engineering, or related field.
- Demonstrated expertise in medical device/combination product development, engineering, and commercialization.
- Experience with complex mechanical/electromechanical delivery systems (e.g., prefilled syringes, autoinjectors, on-body delivery).
- Advanced knowledge of design controls, design verification/validation, risk management, design transfer, and lifecycle management.
- Experience with drug/device integration, manufacturing scale-up, technology transfer, and supplier/partner oversight.
- Thorough understanding of cGMP, quality systems, and global regulatory expectations (FDA, EMA, ISO).
- Knowledge of drug delivery technologies, connected health, human factors/usability, and emerging injectable trends.
- Ability to solve complex technical challenges and influence cross-functional teams.
Preferred Qualifications
- Support regulatory filings, health authority interactions, or commercial launch readiness.
- Experience with external device developers, contract manufacturers, testing labs, or component suppliers.
- Familiarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategies.
- Experience across multiple modalities (peptides, proteins, antibodies, gene therapy).
Benefits
- Annual bonus (target 30% of earned base salary) and eligibility for equity-based long-term incentive program.
- Retirement savings plan (with company match); paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Application instructions
- None stated in the provided text.
- Lead development and lifecycle strategy for drug/device combination products (including prefilled syringe and autoinjector presentations).
- Provide technical ownership for delivery devices and associated primary/secondary packaging from early development through commercialization and post-approval lifecycle management.
- Serve as subject matter expert in combination product development, design controls, device engineering, primary packaging, manufacturing readiness, and drug/device integration.
- Partner cross-functionally across CMC, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and external partners to advance an injectable product pipeline.
Your Contributions (include, But Are Not Limited To)
- Lead strategic planning/execution for clinical and commercial combination product development.
- Own delivery devices and primary packaging/combination product elements across the product lifecycle.
- Develop innovative delivery device solutions (prefilled syringe, autoinjector, and other injectable platforms).
- Lead technical decision-making, risk management, and issue resolution for drug/device integration, device performance, manufacturability, and lifecycle management.
- Ensure timely completion of development, V&V, manufacturing, and technology transfer deliverables.
- Partner with Quality, Regulatory, and external suppliers to meet global regulatory, cGMP, safety, and quality expectations.
- Identify, manage, and oversee external partners for device development, manufacturing, testing, and commercialization.
- Monitor emerging technologies and industry trends in injectable delivery systems.
- Support integration of delivery device and drug strategies across modalities (peptides, proteins, antibodies, gene therapy).
Requirements
- BS/BA (10+ yrs) or MS/MA (8+ yrs) or PhD (5+ yrs) in Mechanical Engineering, Biomedical Engineering, or related field.
- Demonstrated expertise in medical device/combination product development, engineering, and commercialization.
- Experience with complex mechanical/electromechanical delivery systems (e.g., prefilled syringes, autoinjectors, on-body delivery).
- Advanced knowledge of design controls, design verification/validation, risk management, design transfer, and lifecycle management.
- Experience with drug/device integration, manufacturing scale-up, technology transfer, and supplier/partner oversight.
- Thorough understanding of cGMP, quality systems, and global regulatory expectations (FDA, EMA, ISO).
- Knowledge of drug delivery technologies, connected health, human factors/usability, and emerging injectable trends.
- Ability to solve complex technical challenges and influence cross-functional teams.
Preferred Qualifications
- Support regulatory filings, health authority interactions, or commercial launch readiness.
- Experience with external device developers, contract manufacturers, testing labs, or component suppliers.
- Familiarity with primary container closure systems, secondary packaging, human factors engineering, and device constituent part control strategies.
- Experience across multiple modalities (peptides, proteins, antibodies, gene therapy).
Benefits
- Annual bonus (target 30% of earned base salary) and eligibility for equity-based long-term incentive program.
- Retirement savings plan (with company match); paid vacation/holidays/personal days; caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Application instructions
- None stated in the provided text.