Associate Director, Drug Delivery Devices

biomarin; Novato (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

BioMarin seeks an experienced Associate Director to join the Combination Products and Medical Devices team. This role combines strategic and technical responsibilities to develop transformational drug delivery technologies for BioMarin’s portfolio.

The ideal candidate will lead cross-functional device teams, engage with regulatory agencies, and drive device development from inception through commercialization and lifecycle management. Strong collaboration and leadership are essential.

Qualifications

• Minimum 8 years in development and commercialization of parenteral combination products and medical devices.
• Demonstrated ability to manage cross-functional teams and collaborate with stakeholders.
• Experience with parenteral drug delivery devices (pre-filled syringes, autoinjectors, large volume) is highly desirable.
• Deep expertise in design controls and regulatory considerations for devices.
• Experience working with contract manufacturers.
• Exposure to human factors engineering.
• Proven ability to influence across organizational levels.

Responsibilities

• Lead cross-functional project teams to develop delivery devices and combination products for clinical introduction, commercialization, and post‑marketing support.
• Oversee technology development of unique drug delivery technologies as needed.
• Collaborate with CMC, asset teams, quality, regulatory, and external operations.
• Manage external device vendor engagement and strategic oversight of externally developed devices.
• Drive design, development, verification, validation, and transfer of products.
• Lead product and process improvements for on‑market products.
• Coordinate with contract manufacturers to ensure quality and timely deliverables.
• Prepare and present reports to senior management on status, risks, and opportunities.
• Mentor engineers and scientists within the department.
• Ensure compliance with ISO requirements and medical device regulations.

Skills

Cross-functional leadership

Parenteral device delivery

Design controls

Regulatory compliance

Contract manufacturers

Human factors

Stakeholder influence

Education

Bachelor's in engineering

Advanced degree preferred

Job description

BioMarin seeks an experienced Associate Director to join the Combination Products and Medical Devices team. This role combines strategic and technical responsibilities to develop transformational drug delivery technologies for BioMarin’s portfolio.

The ideal candidate will lead cross-functional device teams, engage with regulatory agencies, and drive device development from inception through commercialization and lifecycle management. Strong collaboration and leadership are essential.