Associate Director, Device Development

Who We Are

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options.

More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world‑class manufacturing capabilities.

Bio Marin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain Bio Marin’s cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinate the worldwide movement of our drugs to patients.

Bio Marin is seeking an experienced and motivated Associate Director to join our Combination Products and Medical Devices team. This role is pivotal, encompassing strategic and technical responsibilities. This role provides an opportunity to leverage your device development expertise to develop transformational drug delivery technologies for Bio Marin to meet our long‑term aspirations.

To deliver on this, the candidate must have a proven track record of success working cross‑functionally at senior levels and have experience engaging with all functions involved with device development. The ideal candidate will exhibit a strong technical background in drug delivery systems, deep experience in leading cross‑functional device team leadership, including experience in combination product development, device/combination product manufacturing operations, and drug product development, with a proven track record of successful device/combination product development and commercialization.

This role requires managing senior level stakeholders, a deep understanding of ISO requirements, medical device regulations, and experience in combination products/device development from inception through commercialization and life cycle management. This role demands a high level of expertise in systems engineering fundamentals, mechanical product and process design as well as collaborative operation within a cross‑functional matrix team environment.

• 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…