Lead, Manufacturing; Front End Nights

Overview

Bio Marin is a leading rare disease biotechnology company focused on genetically defined conditions. Our purpose is to develop medicines that make a profound impact on people’s lives. Since our founding in 1997, we have delivered a portfolio of therapies for conditions such as achondroplasia, PKU, CLN2, and various forms of MPS. Following the Amicus acquisition, we expanded to include therapies for Fabry disease and Pompe disease.

Bio Marin’s Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the commercial market. This team builds and maintains manufacturing processes and sites, provides quality assurance and quality control to meet regulatory standards, and coordinates the worldwide movement of our drugs to patients.

Shift Lead, Manufacturing

• Lead daily operations in the area with effective communication, decision-making, troubleshooting, and schedule adherence.
• Coordinate tasks directly to accomplish objectives.
• Provide direction and hands-on training for staff.
• Support staff management with supervision and guidance.
• Live department values and set standards for others to operate by.
• Foster an environment of compliance, strong work ethic, and ongoing learning.
• Take responsibility for moderate-level projects and drive alignment with peer leads across manufacturing to improve processes.
• Partner with Facilities, Validation, Quality, and other support groups to complete scheduled activities.
• Demonstrate strong process knowledge across relevant theory, equipment, and compliance.
• Troubleshoot issues and support resolutions with technical groups; perform ongoing operational tasks in the respective work area.
• Apply scientific thinking and decision making in daily work.
• Support review and approval of documentation including Batch Records and logbooks; assist with closure of Manufacturing quality records (deviations, change requests).
• Other duties as assigned.

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

• Complete understanding and adherence to cGMPs related to commercial operations.
• Support the closure of manufacturing discrepancies and change requests.
• Experience with business systems (PI Process Book, LIMS, Veeva, SAP, MES, etc.).

• 2+ years of relevant industry experience.
• Demonstrated technical expertise in downstream processing.
• Working knowledge of process automation and associated equipment.
• Proven organizational, shift leadership, and communication skills.
• Identify and drive opportunities for process optimization.
• Ability to manage work, actions, and expectations effectively.

B.A./B.S. desired but not required.

Sun/Tues-Sat 6PM-7AM. Saturday is rotating.

This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer / Veterans / Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.