Director, Device Development

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.

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.

• Minimum 10 years of experience in the development and commercialization of combination products and medical devices.
• Experience working with regulatory agencies and ensuring compliance with industry standards.
• Demonstrated ability to manage cross-functional teams and collaborate effectively with stakeholders.
• Exposure to human factors engineering.
• Strong knowledge and experience with ISO standards and regulatory bodies.
• Familiarity with MDRs and design controls.
• Firsthand experience with pen devices, pre-filled syringe, and/or autoinjectors is highly desirable.
• Experience working with contract manufacturers.
• Effective communication skills and demonstrated ability to influence up, down, and across multiple levels and functional areas (corporate wide).

• Expertise in combination products and devices: Possess a blend of pharmaceutical and engineering and regulatory compliance knowledge.
• Experience with human factors engineering: Knowledge and application of human factors engineering principles to ensure user-friendly and safe product designs.
• Experience working with contract manufacturers: Proven experience in collaborating with contract manufacturers to ensure quality and timely delivery of products.
• In-depth knowledge of regulatory requirements for combination products and medical devices: Comprehensive understanding of industry regulations and standards to ensure compliance throughout the product development and commercialization process.
• Proficiency in product development and validation processes: Expertise in designing, developing, and validating combination products and medical devices, ensuring they meet all necessary requirements.
• Strong analytical and problem-solving skills: Ability to analyze complex problems, identify root causes, and develop effective solutions.
• Strong team management skills: Provides constructive facilitation to enable all parties to understand changes or issues and develop solutions to resolve conflicts that best meet the needs of BioMarin.
• Excellent project management and organizational abilities: Proven track record of managing multiple projects simultaneously, ensuring timely delivery and adherence to quality standards.
• Excellent communication and interpersonal skills: Strong verbal and written communication skills, with the ability to effectively convey information to various stakeholders.
• Ability to work effectively in a fast-paced, dynamic environment: Adaptability and resilience in managing changing priorities and demands.
• Strong decision-making skills: Interprets complex and often imprecise sets of information and identifies gaps. Breaks down vague and very complex, multidimensional problems. Can anticipate the right time to make a decision in the absence of clarity.

Expected Behavioral Characteristics

• Accountability
• Achieving Excellence
• Communication
• Courage / Challenge
• Develop Self & Others
• Reliability
Collaboration

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.