Description:
As a critical member of Moderna's Australia Manufacturing Science and Technology (MST) team, you will serve as an expert in visual inspection programs for GMP operations. This role involves leading and developing validation strategies for visual inspection, troubleshooting to support MST and Operation activities, and fostering a culture of continuous learning within the department. You will leverage data analytics to assist in investigations, monitor process performance, and enhance production processes. Collaboration with internal functions to deliver insights that add value to the organization is a key aspect of this role.
Here's What You’ll Do:
- Serve as an MST subject matter expert (SME) on Visual Inspection-related topics.
- Assume operational responsibility for visual inspection (manual, semi-automated, or automatic inspection units).
- Support project teams on complex topics during the design and qualification phases before the operational takeover of new lines.
- Prepare risk analyses (FMEA), develop relevant procedures, and train staff.
- Lead efforts to ensure manufacturing processes are executed safely, efficiently, cost-effectively, and with the required quality.
- Manage a cross-functional team of Process Experts and Technicians within Moderna.
- Facilitate and manage interfaces between Operations and Quality Organization.
- Establish training and awareness programs around visual inspection requirements.
- Contribute to the creation of new quality-related policies and standards.
- Communicate complex technical details effectively to Senior Leadership.
Here’s What You’ll Bring to the Table:
- MS or equivalent in a scientific, engineering, or mathematical discipline with at least 5 years of experience in the pharmaceutical industry.
- An academic degree (PhD/MSc) in pharmaceutical sciences, chemistry, process engineering, or a related field.
- Significant industry experience in aseptic product manufacturing (clinical product and/or commercial product), with proven knowledge of cGMP compliance requirements.
- Experience in both manual and automated visual inspection is advantageous.
- Excellent communication and interaction skills, with experience working across various interfaces within customers and project organizations.
- Fluency in English.
- Prior experience working in a GMP environment.
- The ability to collaborate effectively in a dynamic, cross-functional matrix environment.