Associate Director, Clinical Supply Chain Planning
Location San Rafael, California Workstyle Open to Hybrid Apply
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 – 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.
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. Come join our team and make a meaningful impact on patients’ lives.
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.
In the U.S., the salary range for this position is $ 134,400 to $ 201,600 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Apply 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 – 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.
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. Come join our team and make a meaningful impact on patients’ lives.
SUMMARY DESCRIPTION:
Key interfaces include:
- Product Supply Chain Owner (PSCO)
- Network Planning
- Clinical Operations
- Quality Assurance
- Production Scheduling
- Global External Operations (GEO)
- Enterprise Master Data Management
- Logistics team, packaging engineering and validation
This crucial role is a member of the BioMarin Global Supply Chain and participates in Clinical Supply Chain project initiatives and efforts, including process improvement, and delivering TOPs and SCOPE strategic objectives.
Responsibilities:
- Ensure accurate demand signals and inventory levels are incorporated into the overall supply plan for manufacturing of IP
- Collaborate with domestic and international logistics for shipment of samples, drug product and finished goods to support clinical trials
- Develop supply plans that support clinical program objectives and ensure uninterrupted availability of drug at global study sites. Ensure supply plans effectively incorporate manufacturing capacity and lead times.
- Manage GMP inventory throughout the supply chain, inventory metrics, and manage shelf-life extension
- Participate in developing supply chain management strategies to maximize supply efficiency, minimize waste, identify supply risks, and develop risk mitigation plans
- Establish internal SOPs for supply chain management related activities
- Work with stakeholders to develop, communicate and implement contingency plans for unplanned events
- Prepare, forecast, and manage the production plan and ensure adherence to the approved budget
- Develop and maintain Clinical Supply Chain SOPs/Work Instructions
- Support continuous improvement programs and/or compliance projects that benefit or impact the clinical supply chain business process
- Monitor and collect data on current operations, including scheduling, sourcing, warehousing, production, and delivery
- Analyze data to determine areas for performance improvement
- Investigate pain points within the process and develop solutions to resolve conflicts and inefficiencies
- Lead change management process and controls for the department
- Monitor internal and external industry trends
Must have: Minimum Requirements:
- BS/B.Sc., preferably in the life science, engineering, supply chain or business administration
- Materials management, production planning and scheduling experience
- Biopharma experience, in a complex, virtual, clinical/commercial supply chain environment
- GMP/GCP compliant pharmaceutical operations experience
- APICS certification desirable
- Knowledge in supply chain, planning or materials management, packaging and labeling, logistics including import/export, inventory management, and electronic systems such as IRT or ERP
- Strong organizational, analytical, and interpersonal skills
- Demonstrated ability to work in cross-functional teams with minimal supervision
- Ability to prioritize and manage deadlines in a fast paced, dynamic environment with multiple projects
- Subject-matter expertise in ERP systems, preferably Oracle or SAP
- Ability to understand the impact of unique issues from multiple functional perspectives including Regulatory, Quality, Supply Chain, and Manufacturing to assess best options
- Business process thinker. Drives for continuous improvement of business process to achieve product strategies.
- Demonstrated, deep understanding of end-to-end global supply chain processes
- Ability to work in a global, matrix organization
- Can accommodate required international travel
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.
In the U.S., the salary range for this position is $ 134,400 to $ 201,600 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.