Manufacturing Associate, LNP

Role Summary

Manufacturing Associate, LNP. Responsible for manufacturing activities related to LNP GMP manufacturing in a state-of-the-art facility, including clinical and commercial product manufacture, and ensuring clear communication across departments.

Responsibilities

• Perform clinical / commercial product manufacturing for LNP therapies according to cGMP standards and SOPs including Lipid and RNA Prep, T-Mix, and TFF operations
• Perform aseptic vial filling, visual inspection, cryopreservation, process reagent formulation, and material kitting
• Transfer raw material inside cleanroom suite using sanitizing reagents or equipment
• Participate in technology transfer from Process Development to the Manufacturing group
• Assist in the life cycle development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with PD / MSAT and Quality Systems groups
• Ensure all materials and equipment are identified and available in time for manufacturing operations
• Execute standard work per manufacturing schedule
• Participate in Quality investigations and resolutions
• Ensure cGMP compliance through consistent execution
• Other duties and projects as assigned to meet departmental requirements

Qualifications

• Certificate, associate’s degree or higher in biological sciences or related fields and 2-5 years of relevant Manufacturing experience or related fields
• Available to work a flexible schedule as needed
• Ability to don cleanroom garments and work within a classified environment (Grade B and C)
• Knowledge of GMP and industry standards
• T-Mix and TFF experience preferred
• Fluency in Windows and Microsoft Office applications
• Attentive to detail and accuracy
• Ability to effectively communicate and collaborate with internal stakeholders
• Ability to work effectively in a collaborative team environment with results achieved through influence and follow-through
• Ability to lift 40 pounds
• Ability to stand for 6 hours in a clean room environment
• Self-driven, independently motivated, data driven and excellent problem-solving ability

Skills

• Collaborative teamwork
• Ability to communicate across multiple departments
• Problem-solving and data-driven decision making

Education

• Certificate, Associate’s degree or higher in biological sciences or related field

Additional Requirements

• On-site work required for manufacturing and lab-based positions