Senior Engineer I, Drug Product, MS&T Specialist
hace 1 mes
As a Senior Engineer I, Drug Product, MS&T Specialist at Moderna, you will be part of a pioneering team that's revolutionizing medicine through mRNA technology. You will work alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
This role is part of the Drug Product (DP) team, tasked with technical support of GMP operations across international and US sites. You will play a crucial role in liaising with DP Contract Manufacturing Organizations (CMOs) and Moderna sites to drive forward the portfolio of projects and initiatives supporting commercial lifecycle management, technology transfer, and drug product technologies.
Key Responsibilities
• Supporting continuous improvement initiatives and complex technical projects for DP and Aseptic manufacturing operations globally.
• Collaborating with Moderna's DP Operations to establish robust and compliant manufacturing performance at drug product CMOs.
• Partnering with Technical development to investigate and resolve complex manufacturing issues at CMOs.
Additional Responsibilities
• Writing or revising the appropriate GMP documentations.
• Automating, visualizing, and analyzing QC data and metrics, identifying trends and patterns, analyzing causality, formulating improvement proposals, and converting the insights with business teams to actions and plans for measurable business improvements.
• Representing MST as a subject matter expert (SME) on DP manufacturing data analysis with Digital, Operations, and Technical Development teams.
• Contributing to our process data management and overall knowledge management strategy.
Moderna Mindsets
• Prioritize the platform: Your work prioritizes our platform of mRNA technology, ensuring that every effort is aimed at enhancing our capability to deliver outstanding results.
• Act with dynamic range: You'll need the ability to drive both strategy and execution simultaneously, adapting to new data and changing contexts swiftly and effectively.
Requirements
• MS or equivalent in a scientific, engineering or mathematical discipline with 5+ years' experience in the pharmaceutical industry, Ph. D level with 0+ years' experience. BS applicants with 8+ years' relevant experience will also be considered.
• Proficiency in English required.
• Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment.
• Prior experience in aseptic manufacturing.
• Prior experience with DP operations and/or Laboratory Instruments
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