Associate Engineering Director, Combination Drug Product/Device

Neurocrine Biosciences; San Diego (CA); On-site; USD 173,600 - 237,000; Full time

Benefits offered by this job

Retirement savings plan with company match

Paid vacation and personal days

Health benefits including medical, dental, and vision

30% target bonus

Job summary

Neurocrine Biosciences is seeking an Associate Director of Drug/Device Combination Products in San Diego to lead the development of innovative delivery device solutions.

The role requires extensive experience in combination product development and a strong technical background in mechanical or biomedical engineering. Candidates must possess excellent leadership and communication skills, with a focus on cross-functional collaboration in a dynamic environment.

Qualifications

• 10+ years of industry experience with a BS/BA, 8+ years with an MS/MA, or 5+ years with a PhD.
• Demonstrated expertise in medical device or combination product development and commercialization.
• Experience with mechanical or electromechanical delivery systems including prefilled syringes.

Responsibilities

• Lead strategic planning for drug/device combination product development.
• Provide technical ownership for delivery devices and primary packaging.
• Partner with Quality and Regulatory to meet compliance and quality expectations.

Skills

Medical device development

Combination product engineering

Risk management

Design controls

Cross-functional collaboration

Education

PhD in Mechanical Engineering or Biomedical Engineering

MS in Mechanical Engineering or Biomedical Engineering

BS in Mechanical Engineering or Biomedical Engineering

Job description

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.

Responsibilities

• 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

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
• Demonstrated expertise in medical device or combination product development, engineering, and commercialization
• Experience developing combination products leveraging complex mechanical or electromechanical delivery systems, preferably including prefilled syringes, autoinjectors, on‑body delivery systems, or related injectable platforms
• Advanced knowledge of design controls, design verification and validation, risk management, design transfer, and lifecycle management
• Experience with drug/device integration, 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

Compensation and Benefits

The annual base salary is expected to be $173,600.00-$237,000.00, with a target bonus of 30% of earned base salary and eligibility to participate in our equity‑based long‑term incentive program. Benefits 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.

EEO Statement

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.