Manufacturing Associate II, Drug Substance Operations

Responsibilities

• Execute manufacturing unit operations for mRNA and LMX/LNP drug substance in a GMP-regulated clean-room environment.
• Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Utilize "reader-doer" protocols for all steps outlined in standard operating procedures (SOPs) and batch execution documentation.
• Maintain Good Documentation Practices (GDP) and Data Integrity to ensure all records are audit-ready.
• Perform aseptic processing, including chromatography, multiple filtration methods, and nano-mixing operations.
• Conduct filling and dispensing activities to final container closure for finished drug substance.
• Utilize manufacturing support systems such as SAP, VEEVA, Delta V, Syncade, LIMS, and CMMS.
• Act as a Qualified Trainer to perform On the Job Training (OJTs) for colleagues on unit operations.

Requirements

• HS Diploma with 5 years of industry experience, OR
• Associates degree with 3-5 years of industry experience, OR
• STEM degree with 2-3 years of industry experience.
• Working understanding of GMP regulations.
• Ability to work in a clean-room environment (Grade C).
• Ability to perform physical activities including standing and lifting for periods of time.

Benefits

• Best-in-class healthcare coverage and voluntary benefit programs.
• Holistic well-being support, including fitness, mindfulness, and mental health resources.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, and global recharge days.
• Savings and investment opportunities.

About the Company

Moderna is pioneering the development of a new class of drugs made of messenger RNA (mRNA). We are building the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered to patients worldwide.