Manufacturing Associate II

Role Summary

Manufacturing Associate II at Maravai LifeSciences. Primary producer within the operational unit, guiding new team members in learning technologies; produces research and clinical grade components and products by setting up, cleaning, operating, and maintaining equipment within ISO classified space.

Responsibilities

• Reviews production schedules, clarifies specifications, calculates requirements, assembles materials and supplies, and executes assigned production tasks
• Prepares production areas for cGMP project initiation or changeover
• Documents production activities by accurately completing forms, reports, logs, and batch records in compliance with GDP standards
• Keeps equipment operating by following procedures, performing preventive maintenance, troubleshooting breakdowns, and coordinating repairs as needed
• Writes, reviews, and executes batch records and SOP revisions while maintaining quality documentation
• Leads, mentors, and trains manufacturing personnel to ensure adherence to production schedules, troubleshoot processes, and drive continuous improvement
• Participates in ongoing training programs and ensures timely completion of all cGMP and company training requirements
• Maintains a safe and clean work environment in accordance with SOPs and safety guidelines
• Provides written and verbal updates to supervisors and department managers
• Collaborates with manufacturing support groups to align on production requirements and project priorities
• Troubleshoots equipment and production processes, identifies bottlenecks, and implements preventive and continuous improvement initiatives
• Onboards new equipment with minimal supervision
• May perform fermentation, pDNA linearization, IVT reactions, tangential flow filtration, and chromatography using equipment such as 3L or 30L fermenters, Spectrum TFF systems, and AKTA HPLCs
• May perform enzymatic reactions, utilizing purification systems and documenting activities in accordance with SOPs and batch records
• May perform gram-to-kilogram scale chemical synthesis, organic reactions, precipitations, extractions, deprotections, and liquid chromatography (analytical to large scale), as well as fill-finish and aliquoting of mRNA capping reagents, modified NTPs, and related raw materials
• May perform oligonucleotide synthesis using automated synthesizers, purification (RP, AX, IP, PAGE), post-purification reactions (amine/thiol conjugations), and 5‚Ä≤-cap and 5‚Ä≤-triphosphate modifications
• Performs other duties as assigned

Qualifications

• Bachelor's Degree in life science field or related field preferably in Chemistry/Biochemistry/Biology/Molecular Biology or equivalent experience
• 2+ years of experience in a Biochemistry manufacturing laboratory
• Exposure in a cGMP/ ISO 7/ ISO 8 clean room environment desired
• Experience with drafting, editing, implementing, and executing SOPs
• Proficiency in Microsoft Office Suite desired
• Display strong organizational skills, detail-oriented, and demonstrated problem-solving abilities
• Excellent written and verbal communication skills
• Self-motivated and able to organize and prioritize multiple tasks
• Previous experience with chemical synthesis methodology and purification functionality of mRNA capping reagents, modified NTPs, and biotech supporting raw materials from a 1-500g scale following cGMP procedures desired

Skills

• Biochemistry manufacturing
• cGMP/documentation
• Equipment maintenance and troubleshooting
• Process improvement and mentorship
• SOP development and compliance
• Communication and collaboration

Education

• Bachelor's Degree in life sciences or related field