Manufacturing Associate II

Role Summary

Manufacturing Associate II at Maravai LifeSciences. Primary producer within the operational unit, guiding new team members in learning technologies and producing research and clinical grade components 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

• Manufacturing operations in cGMP environments
• Documentation and batch record management
• Equipment maintenance and troubleshooting
• Process improvement and mentoring
• Oligonucleotide synthesis and related purification techniques (RP, AX, IP, PAGE)

Education

• Bachelor's Degree in life sciences or related field