Associate Director, Device Development

BioSpace; Novato (CA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

BioMarin is seeking an experienced Associate Director to join our Combination Products and Medical Devices team in Novato. This role combines strategic leadership with hands-on device development, driving advanced drug delivery solutions from concept through commercialization.

The ideal candidate will lead cross-functional teams, manage senior-level stakeholders, ensure ISO and regulatory compliance, and partner with CMC, quality, and external manufacturers to deliver innovative delivery devices

Qualifications

• Minimum 8 years of experience in the development and commercialization of parenteral combination products and medical devices.
• Experience leading cross-functional device teams and commercialization of delivery technologies.
• Deep expertise in design controls and working with regulatory agencies.

Responsibilities

• Lead cross-functional project teams in developing complex delivery device and combination product technologies for clinical introduction and commercialization.
• Oversee technology development of unique drug delivery technologies.
• Partner with CMC, quality, regulatory, external operations and other functions.
• Lead external device vendor engagement and strategic oversight of externally developed device technologies.
• Drive design, development, verification, validation, and transfer of combination products and medical devices.
• Lead product and process improvements for on-market products.
• Collaborate with contract manufacturers to ensure quality and timely delivery of deliverables.
• Prepare and present reports to senior management on project status, risks, and opportunities.
• Mentor engineers and scientists within the department.
• Maintain knowledge of global regulatory requirements and industry standards.

Skills

Cross-functional leadership

Parenteral drug delivery

Device development

Design controls

Regulatory knowledge

Stakeholder management

Vendor engagement

Leadership of device teams

Communication skills

Education

Bachelor’s degree in engineering or life sciences

Job description

Who We Are

BioMarin 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. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

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.

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. To deliver on this, the candidate must have a proven track record of success working cross-functional 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.

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.
• Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.
• Other duties as assigned.

Experience

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 (corporate wide).

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.

CONTACTS

Device engineers, device quality, device regulatory, external manufacturing, drug product formulation scientists, supply chain engineers, asset team members like clinical and commercial.

ONSITE, REMOTE, OR FLEXIBLE

Hybrid. 3 days a week in Novato

Travel Required

Up to 10% domestic and international travel

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.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.