Engineer II, LNP Process Development

Aldevron • Fargo, ND

122d

About The Position

The Process Development Engineer II role is responsible for onboarding and overseeing multiple new technical transfer projects involving Drug Product life cycles from development through clinical and commercial applications from both internal and external sending parties. This position reports to the Sr Manager of RNA Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role. In this role, you will have the opportunity to design, execute and oversee DOEs, experiments and subsequent summary reports, lead and facilitate the onboarding of technical transfers throughout the product life cycle, drive and lead cross functional initiatives, training, and communication, execute and lead change controls and quality event investigations, and steer both internal and external parties as the subject matter expert (SME) providing technical support in a timely manner.

Requirements

• BS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 4+ years of experience OR a MS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 2+ years of experience OR a PhD in biology, molecular biology, biochemistry, chemistry, or related discipline with 1+ years of experience
• Experience in RNA/LNP technical transfer through manufacturing, experimental design, and data analysis within a cGMP environment
• Ability to apply critical thinking and manage multiple projects in flight with a robust knowledge in biologics downstream bioprocessing

Nice To Haves

• Working knowledge of current industry drug substance and drug product guidelines

Responsibilities

• Design, execute and oversee DOEs, experiments and subsequent summary reports
• Lead and facilitate the onboarding of technical transfers throughout the product life cycle
• Drive and lead cross functional initiatives, training, and communication
• Execute and lead change controls and quality event investigations
• Steer both internal and external parties as the subject matter expert (SME) providing technical support in a timely manner

Benefits

• Comprehensive health care program
• Paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing