Sr. Director, Device Development
Description
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.
- Support all BMRN combination device commercial products
- 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.
- Support early-stage development programs to advance BMRN product pipeline.
- Ownership of product complaint investigations to support BMRN combination device commercial products.
- 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.
- Prepare and present reports to senior management on project status, risks, and opportunities.
- Work closely with contract manufacturers to ensure quality and timely delivery of products.
- Lead and/or support device CDMO or other device development service provider selections and site due diligence evaluations and visits.
- Oversight of device project deliverables, budgeting and financial accrual.
Education Required
Bachelor’s degree in engineering, Life Sciences, or a related field. Advanced degree preferred.
Experience Required
- Minimum 12 years of experience in the development and commercialization of combination products and medical devices.
- Proven track record of successful project management and team leadership.
- Experience working with regulatory agencies and ensuring compliance with industry standards.
- Demonstrated ability to manage cross-functional teams and collaborate effectively with stakeholders.
- Experience with 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).
Competencies Required
- 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 leadership: Leads teams with vision and purpose, ensuring alignment of department and function goals with BioMarin objectives. Ability to lead and mentor a team of engineers and scientists, fostering a collaborative and productive work environment.
- 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.
- Strong agility skills: Able to review recommended plans from subordinates and anticipates impact on other departments or external stakeholders. Provides guidance and checks on subordinates’ responses to unexpected situations. Uses knowledge and experience to quickly analyze situations and approve revised plans.
Expected Behavioral Characteristics
- Accountability
- Achieving Excellence
- Communication
- Courage / Challenge
- Develop Self & Others
- Reliability
- Collaboration
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.
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 any other characteristic protected by law.
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 any other characteristic protected by law.