Sr Process Development Engineer

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Aldevron, one of Danahers 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you'll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potentialone discovery at a time.

The Sr Process Development Engineer role is responsible for overseeing multiple new technical transfer activities involving Drug Substance and Drug Product program life cycles from development through clinical and commercial applications from both internal and external sending parties with a specialization in LNP Drug Product.

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 new process unit operations and bring innovative ideas to troubleshoot problems
• Lead and facilitate the onboarding of technical transfers throughout the product life cycle and steer later phase application programs to meet clinical standards
• Mentor other teammates in Tech Ops and other crossfunctional teams through training of innovative initiatives, optimizations, and unit operations
• Execute and lead change controls, quality event investigations, and support process qualification/validation initiatives
• Steer both internal and external parties as the subject matter expert (SME) providing technical support in a timely manner to drive on time delivery and right first time metrics

The essential requirements of the job include:

• BS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 6+ years of experience.
• MS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 3+ years of experience.
• PhD in biology, molecular biology, biochemistry, chemistry, or related discipline with 3+ years of experience.
• Experience in leading RNA/LNP technical transfer projects through manufacturing, experimental design, and data analysis life cycles in a cGMP environment
• Ability to apply critical thinking and oversee multiple projects in flight with robust knowledge of processes and procedures required to lead end to end programs throughout the products life cycle.

It would be a plus if you also possess previous experience in:

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

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.