Associate Director, Device Development (Hybrid)

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

Job summary

BioMarin is seeking an experienced Associate Director to join our Combination Products and Medical Devices team in Novato. This role blends strategic leadership with hands-on device development to deliver innovative drug-delivery technologies.

The ideal candidate has 8+ years in parenteral products, extensive cross-functional collaboration, and deep knowledge of design controls and regulatory pathways. Hybrid onsite work, partnering with CMC, QA, and regulatory teams, with travel up to 10%.

Qualifications

• Minimum 8 years in the development and commercialization of parenteral combination products and medical devices.
• Proven ability to manage cross-functional teams and collaborate effectively with stakeholders.
• Firsthand experience with parenteral drug delivery with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable.
• Deep expertise in design controls.
• Experience working with contract manufacturers.
• Exposure to human factors engineering.
• Working with regulatory agencies and ensuring compliance with industry standards.
• Effective communication skills and demonstrated ability to influence up, down, and across multiple levels and functional areas (corporate wide).

Responsibilities

• Lead highly visible cross-functional project teams in developing complex delivery device and combination product technologies with the goal of clinical introduction, commercialization, and post marketing support.
• As needed, lead technology development of unique drug delivery technologies.
• Partner with key stakeholders like CMC teams, asset teams, quality, regulatory, external operations and other functions.
• Lead external device vendor engagement and strategic oversight of externally developed device technologies.
• As a device team leader, drive the design, development, verification, validation, and transfer of combination products and medical devices.
• Lead product and process improvement related to on market products.
• Work closely with contract manufacturers to ensure quality and timely delivery of project deliverables.
• Prepare and present reports to senior management on project status, risks, and opportunities.
• Mentor engineers and scientists within the department.
• Knowledge of global regulatory requirements and industry standards.
• Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.
• Other duties as assigned.

Skills

Cross-functional leadership

Parenteral delivery

Device development

Design controls

Regulatory collaboration

Contract manufacturers

Human factors

Stakeholder influence

Education

Bachelor’s degree in engineering/Life sciences

Advanced degree preferred

Job description

BioMarin is seeking an experienced Associate Director to join our Combination Products and Medical Devices team in Novato. This role blends strategic leadership with hands-on device development to deliver innovative drug-delivery technologies.

The ideal candidate has 8+ years in parenteral products, extensive cross-functional collaboration, and deep knowledge of design controls and regulatory pathways. Hybrid onsite work, partnering with CMC, QA, and regulatory teams, with travel up to 10%.