Jobs and Careers

Director, Device Development

United Statesfull_timeVerifiedPosted 5 Mar 2025

About the role

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

Drug Product and Device Technologies (DPDT) is comprised of a team of scientists and engineers responsible for Drug Product and Device development, including commercial product & packaging development. DPDT is responsible for end-to-end development of drug products and devices in collaboration with multi-disciplinary partners. The DPDT team delivers stable formulations, reliable processes, and technologies for drug products, combination products, and administration components from early to late stage for various modalities, including small molecules, oligonucleotides, gene therapy, peptides, and proteins. We develop platform strategies to enable fast to patient approaches, including DP (Drug Product) and Device development and overseeing commercial manufacturing & packaging for outsourced programs.

Role Summary

BioMarin is seeking an experienced and motivated Director to join our Combination Products and Medical Devices team in Technical Development. 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 BioMarin 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, 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, and cross-functional team leadership. This role requires a deep understanding of ISO requirements, medical device regulations, and experience in combination products/device development from inception through commercialization and life cycle management. Scope and 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.
Lead technology development of unique drug delivery technologies as needed.
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, including human factors engineering integration into product development.
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.
Deep knowledge of global regulatory requirements and industry standards.
Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.