Jobs and Careers

Sr. Director, Device Development

United States, United Statesfull_timeVerifiedPosted 1 Oct 2024

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.

Our Culture

BioMarin’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 BioMarin’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 coordinating the worldwide movement of our drugs to patients.

Drug Product and Device Technologies (DPDT) is comprised of a team of scientists 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. DPDT team delivers stable formulations, reliable processes and technologies for drug product, 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.

Scope and Responsibilities

Provides strategic leadership and vision, guides cross-functional teams, foster collaboration, and drive the execution of our product development plans.

Regularly influences peers and executives. Serves as a principal spokesperson for the combination product and device organization unit.

Secures internal and external strategic alliances or partnerships with top executives to support and expand BioMarin’s growth.

Lead the development and implementation of combination products and medical devices strategies.

Oversee the design, development, verification, validation and transfer of combination products and medical devices, including human factors engineering integration into product development

Ensure compliance with regulatory requirements and industry standards.

Collaborate with cross-functional teams to drive product development and commercialization.

Manage and mentor a team of engineers and scientists.

Develop and maintain relationships with key stakeholders, including regulatory agencies, suppliers, and customers. Monitor industry trends and advancements to ensure the company's products remain competitive.