Lead, Manufacturing; Front End Nights

About Bio Marin

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options.

More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world‑class manufacturing capabilities. At the heart of Bio Marin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

Bio Marin’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 Bio Marin’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 coordinate the worldwide movement of our drugs to patients.

GMP personnel throughout Bio Marin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and maintaining Bio Marin’s innovative manufacturing processes and facilities, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution of our drugs to patients.

• Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherence with minimal oversight.
• Accomplishes tasks through direct and effective coordination.
• Provides direction and hands‑on training for staff.
• Supports the management of staff with supervisor.
• Lives department values and sets the standards for others to operate.
• Fosters an environment of compliance, strong work ethic and ongoing learning.

• Ability to take responsibility for moderate level projects.
• Effective interaction with peer Leads across manufacturing to create alignment and improvement.
• Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities.

• Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance.
• Ability to troubleshoot, identify issues and support resolutions with technical groups.
• Required to perform ongoing operational tasks in respective work area.
• Uses scientific thinking and decision making in daily work.

• Proven experience with relevant process, theory and equipment.
• Experience with process automation and functionality.
• Assist with review and approval of documentation including Batch Records and logbooks.
• Support the closure of Manufacturing owned Quality Records (deviations, change requests).
• Other duties as assigned.

• Provide feedback and/or suggested changes to operational procedures.
• Assist in the incorporation of new technologies, practices and standards into procedures.
• Capable of writing and reviewing process documents.

• Complete understanding and adherence to cGMP’s as related to commercial operations.
• Support the closure of manufacturing discrepancies and change requests.
• Experience with business systems (PI Process Book, LIMS, Veeva, SAP, MES,…