Sr. Director, Manufacturing Sciences and Technology (MSAT)
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
The Senior Director of Manufacturing Sciences and Technology (MSAT) is a key leadership position at the Novato Site that directly supports product supply, strategic BioMarin objectives, and other programs at the Novato Manufacturing campus. Under the leadership of the Senior Director, the MSAT team is responsible for technical and process support of commercial and clinical cGMP Manufacturing utilizing multiple production platforms.
The Senior Director of MSAT reports to the VP of Novato Operations and is a member of the Novato Site Leadership Team.
Key responsibilities include, but are not limited to:
- Capable of leading a large and diverse team of senior scientists and engineers responsible for technical floor support of ongoing manufacturing cell culture, fermentation and purification processes.
- Responsible for managing a team dedicated to the management and analysis of critical manufacturing data and process modeling
- Provide guidance and leadership in the diagnosis and resolution of complex production problems.
- Lead a team of specialists responsible for effective transfer of processes and technology from the Process Development group into a cGMP Manufacturing environment
- Maintain a high level of scientific and technical knowledge of biologics manufacturing and direct a lab-based group of scientists capable of performing scale-down models of cell culture and purification processes with their associated analytical methods to support on-going process investigations, changes, validation, and process improvement initiatives.
- Develop and/or test the feasibility of new manufacturing technologies and their introduction into a cGMP environment.
- Interface with Manufacturing, Quality, Regulatory and Process Development to facilitate efficient technology transfer of new production processes and change control.
- Champion harmonization and alignment across the BioMarin global manufacturing network.
- Provide project management oversight to ensure effective resource utilization, planning, and execution of projects that are in alignment with Novato Site objectives.
- Responsible for ensuring top performance management by personnel in the MSAT organization in delivering high quality work to meet the demands of the site.
- Recruit, direct, coach and develop talent in the MSAT organization to maintain a high level of technical expertise that works collaboratively with key partners.
- Lead budget planning process including capital equipment and material needs, staffing requirements, and contracted services requirements.
- Minimum of 15 years of experience developing and/or supporting commercial scale cGMP manufacturing of biologics
- Has a strong working knowledge of the Quality and Regulatory aspects of cGMP production of biologics.
- Demonstrated to lead and develop an effective team of senior scientists and engineers
- Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
- Creative problem solving skills.
- Experience leading transformational change.
- Experience collaborating effectively with other functional groups to achieve business objectives.