Job Description

This role is Hybrid, requiring 2-4 days onsite weekly in Novato, CA.

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.

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.

Organization and Role Overview

The Vice President of Analytical Sciences leads BioMarin’s end-to-end Analytical Sciences organization, providing strategic and technical direction across the entire product lifecycle, from early development to commercialization. With BioMarin’s diverse portfolio of modalities, this role oversees analytical control strategies, analytical technical development, method transfers, characterization and technical stewardship for both the clinical pipeline and commercial products. Reporting to the SVP of Technical Development & Services, the VP is a key member of the Global Technical Operations extended leadership team.

The VP of Analytical Sciences is responsible for:

• Leading the analytical teams supporting technical stewardship. Developing consistent analytical models which encompass support for drug substance and drug product across all phases of product development and lifecycle management at BioMarin.
• Ensure delivery of technologies and analytical methods that supports the pipeline, including supporting analytical transfers and troubleshooting in laboratories.
• Developing and implementing strategy to sustain robust analytical technical support of QC Labs.
• Collaborate with Drug Product, Durg Substance, Quality, and Regulatory functions to ensure alignment of business processes, governance processes, and technology related to laboratory operations.
• Draft and approve CMC sections in regulatory filings, support agency interactions and inspections.
• Engage in the external environment related to analytical characterization, method development, scientific advancements, and new modalities.
• Ensure knowledge in the production processes and analytical control strategies supporting a variety of modalities including synthetic, biologics, peptides, oligonucleotides, and Gene Therapy.
• Provide leadership to the investigations & forensics teams that deliver on complex analysis and ensure product safety and adherence to regulations.
• Responsible for IPC/release testing activities for phase 1 / 2.
• Mentor and nurture talent.

Education

• Bachelor’s degree in chemistry, Biochemistry, Microbiology, biochemical engineering, or strongly related field.

Experience

• Minimum of 15 years of experience in analytical development or QC laboratories within the pharmaceutical industry, with at least 5 years in a leadership role.
• Extensive knowledge of analytical methodologies, regulatory guidelines, and industry best practices.
• Proven experience in R&D or Operations Quality operations in pharma including analytical technologies, method development and transfers, and QC labs.
• Demonstrated leadership skills with the ability to build high-performing teams
• Visionary leader who can drive innovation and operational excellence while maintaining the highest standards of quality and compliance.

Additional Skills/Preferences Includes

• Ph.D. in analytical, biochemistry, chemical engineering, or relevant scientific discipline
• Expertise in analytical techniques such as HPLC, Mass Spec, Bioassay, and spectrophotometry
• Extensive knowledge of GMP and other pharmaceutical industry regulations and standards.
• Strong knowledge of CMC regulations and pharmacopeia requirements.
• Communicate effectively with all levels of management.
• Demonstrate a breadth of diverse leadership experiences and capabilities instrumental in shaping the future of our laboratories and QC operations.
• Demonstrate qualities such as collaboration, accountability, influence, strategic vision.
• Recognizes the value of diverse teams, models inclusion, and embed the importance of diversity in team management.

Additional Information Includes

• This position will oversee a team in both Novato, CA and Ireland. May require travel to both domestic and international destinations.
• This role is Hybrid, requiring 2-4 days onsite weekly in Novato, CA.

Job Tags

Similar Jobs