Manufacturing Associate II, Oligo

TriLink BioTechnologies • San Diego, CA

12d • $25 - $30 • Onsite

About The Position

Maravai LifeSciences is seeking a Manufacturing Associate II, Oligo to join their Oligo Manufacturing team. The Manufacturing Associate II, Oligo is responsible for executing daily manufacturing operations to produce research- and clinical-grade oligonucleotide products in accordance with established procedures and quality standards. This role supports production activities within ISO-classified environments, including equipment setup, operation, cleaning, maintenance, and troubleshooting. The Manufacturing Associate II collaborates with cross-functional teams to ensure efficient production, adherence to cGMP requirements, and timely completion of manufacturing schedules. Additionally, this position provides technical guidance and training to junior manufacturing personnel while supporting continuous improvement initiatives.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biology, Molecular Biology, or a related scientific discipline, or equivalent combination of education and relevant experience.
• Minimum of 2 years of experience in a biochemistry, biotechnology, or related manufacturing laboratory environment.
• Experience following, reviewing, and executing standard operating procedures (SOPs) and maintaining accurate manufacturing documentation.
• Strong organizational skills, attention to detail, and demonstrated ability to troubleshoot and resolve technical issues.
• Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams.
• Ability to work independently, manage competing priorities, and meet established production timelines.
• Experience working in a current Good Manufacturing Practice (cGMP) environment, including ISO Class 7 or ISO Class 8 cleanrooms.
• Experience drafting, revising, and implementing SOPs, batch records, and other controlled manufacturing documents.
• Hands-on experience with chemical synthesis and purification processes involving mRNA capping reagents, modified nucleoside triphosphates (NTPs), or other biotechnology raw materials at scales ranging from 1 to 500 grams.
• Familiarity with manufacturing equipment operation, troubleshooting, preventive maintenance, and process improvement initiatives.
• Proficiency in Microsoft Office Suite, including Word, Excel, and Outlook.

Responsibilities

• Review production schedules, interpret manufacturing specifications, calculate material requirements, and coordinate resources to ensure timely execution of production activities.
• Prepare manufacturing areas, equipment, and materials for cGMP production activities, including project initiation and changeovers.
• Execute manufacturing processes in accordance with approved standard operating procedures (SOPs), batch records, and cGMP requirements.
• Accurately complete batch records, production logs, equipment records, and other required documentation in compliance with Good Documentation Practices (GDP).
• Operate, maintain, and troubleshoot manufacturing equipment, perform routine preventive maintenance, and coordinate repairs as needed.
• Author, review, revise, and execute batch records, SOPs, and other controlled manufacturing documents.
• Train, mentor, and provide technical guidance to manufacturing personnel, ensuring adherence to established procedures, quality standards, and production timelines.
• Support onboarding, qualification, and implementation of new manufacturing equipment and processes with minimal supervision.
• Identify and troubleshoot manufacturing process issues, evaluate production bottlenecks, and implement continuous improvement initiatives to enhance operational efficiency and product quality.
• Collaborate with Process Development, Quality, Engineering, and other cross-functional teams to support production requirements, process transfers, and manufacturing improvements.
• Provide timely written and verbal updates to supervisors and cross-functional stakeholders regarding production progress, technical challenges, and operational priorities.
• Maintain a safe, clean, and compliant manufacturing environment in accordance with established SOPs, safety requirements, and cGMP standards.
• Complete required training within established timelines and maintain compliance with applicable company policies and regulatory requirements.
• Perform plasmid DNA (pDNA) digestion, in vitro transcription (IVT), purification, and related manufacturing processes using specialized equipment in accordance with approved procedures.
• Execute enzymatic reactions and purification processes, including operation of purification systems, preparation of batch documentation, and implementation of SOPs.
• Perform gram-to-kilogram-scale chemical synthesis, including organic reactions, precipitation, salt exchange, extraction, deprotection, chromatography, fill-finish, and aliquoting of mRNA capping reagents, modified nucleoside triphosphates (NTPs), and other biotechnology raw materials.
• Perform synthetic oligonucleotide manufacturing activities, including chemical reactions, purification, processing, and associated batch documentation.
• Perform other functions and duties as required.

Benefits

• Potential to change, improve, and save lives around the world.
• Opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
• Comprehensive medical plans and HSA/FSA options.
• Fertility & family planning assistance.
• A variety of additional optional benefits and insurance options, including pet insurance.
• Retirement contributions.
• Holidays & Paid Time Off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level