Director CMC Leadership

Profile

Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. BioMarinu2019s 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 BioMarinu2019s 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. Come join our team and make a meaningful impact on patientsu2019 lives. QUALIFICATIONS AND EXPERIENCE Minimum of 8-10 years of experience with strong knowledge drug development, clinical and commercialization processes including: Process and Product development, CMC Regulatory Affairs, Quality, Supply Chain, and/or Biotech Manufacturing Operations. Demonstrated ability to build, organize and lead teams. Proven track record in a fast-paced, challenging, and complex matrixed team environment. Demonstrated strategic thinking capabilities with forward looking perspective. Financial acumen skills including an understanding of financial analysis, performance metrics, and budgeting. High degree of demonstrated learning agility. Strong interpersonal skills; fluent and able to influence others in spoken and written English. Solid understanding and development of product CMCs. Strong risk management analysis and project management skills. Ability to understand the big picture and focus on execution details to CMC product strategies. Effective ability to educate and lead through influence management. Ability to understand impact of unique issues from multiple functional perspectives. Minimum Bachelorsu2019 degree in scientific/engineering discipline. Advanced degree a plus.u00A0Nice to Have Skills and Experience: Lean-DMAIC expertise, Green belt or higher certification. Strong regulatory and GMP acumen, specifically ICH8-12. Rare disease and/or Cell/Gene Therapy operations experience.u00A0This is a hybrid position, requiring a minimum of 2 days per week onsite in Novato, CA. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. 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.

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