Associate Director, Device & Combination Product (Hybrid)

BioMarin Pharmaceutical Inc.; Novato (CA); Hybrid; USD 180,000 - 230,000; Full time

Job summary

BioMarin is seeking an experienced Associate Director to join our Combination Products and Medical Devices team in Novato. This role combines strategic oversight with hands-on technical leadership to advance delivery systems and device technologies.

You will lead cross-functional teams, manage device development from inception through commercialization, supervise external partners, ensure ISO and regulatory compliance, and mentor engineers and scientists across the department.

Qualifications

• 8+ years in parenteral combination products and medical devices.
• Experience leading cross-functional teams with senior stakeholders.
• Strong design controls experience and regulatory engagement.

Responsibilities

• Lead cross-functional teams to develop delivery device and combination products.
• Drive drug delivery technology development with device focus.
• Collaborate with CMC, regulatory, quality, and external operations.
• Manage external device vendor relationships and strategic oversight.
• Guide design, verification, validation, and transfer of products.
• Mentor engineers and scientists within the department.
• Present reports to senior management on status and risks.

Skills

Parenteral products

Medical devices

Cross-functional leadership

Design controls

Regulatory compliance

Contract manufacturers

Human factors

Stakeholder influence

Communication skills

Education

Bachelor's in engineering

Job description

BioMarin is seeking an experienced Associate Director to join our Combination Products and Medical Devices team in Novato. This role combines strategic oversight with hands-on technical leadership to advance delivery systems and device technologies.

You will lead cross-functional teams, manage device development from inception through commercialization, supervise external partners, ensure ISO and regulatory compliance, and mentor engineers and scientists across the department.