Director, Device Development
BioMarin Pharmaceutical Inc.
Summary
BioMarin 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 BioMarin to meet our long-term aspirations. 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.
Job description
Summary
BioMarin 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 BioMarin to meet our long-term aspirations. 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.
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.
Required Skills
- Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices.
- Demonstrated 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.
Desired Skills
- Worked at large-mid sized pharma and/or biotechnology companies focused on developing parenteral combination products.
- Led cross-functional device teams and commercialized prefilled syringes, autoinjectors, and/or pen devices.
- Worked with industry standard primary container technologies like prefilled syringes, cartridges, and vials.
- Experience with lyophilized product related drug delivery.
Education
Bachelor's degree in engineering, Life Sciences, or a related field. Advanced degree preferred.
Requirements
- Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices
- Demonstrated ability to manage cross-functional teams and collaborate effectively with stakeholders
- 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
- Bachelor's degree in engineering, Life Sciences, or a related field
- Advanced degree preferred
- Firsthand experience with parenteral drug delivery with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable
- Worked at large-mid sized pharma and/or biotechnology companies focused on developing parenteral combination products
- Led cross-functional device teams and commercialized prefilled syringes, autoinjectors, and/or pen devices
- Worked with industry standard primary container technologies like prefilled syringes, cartridges, and vials
- Experience with lyophilized product related drug delivery
Company overview
BioMarin Pharmaceutical Inc. is a leading global biotechnology company headquartered in San Rafael, California, specializing in the development and commercialization of innovative therapies for rare genetic diseases. Founded in 1997, the company has established itself as a pioneer in enzyme replacement therapies (ERTs) and genetic medicine, with a focus on addressing the root causes of serious, life-threatening conditions primarily affecting children. BioMarin's portfolio includes eight commercial therapies targeting various rare disorders, including mucopolysaccharidosis, phenylketonuria (PKU), achondroplasia, and hemophilia A. The company's groundbreaking work includes being the first to provide therapeutics for mucopolysaccharidosis type I and phenylketonuria. With approximately 3,000-3,500 employees worldwide and operations across North America, Europe, Asia Pacific, and South America, BioMarin maintains a strong commitment to transforming lives through genetic discovery. The company's research and development efforts continue to advance a robust pipeline of product candidates, applying a science-driven, patient-forward approach to address broader groups of genetic disorders.