Scientist II, RNA

Bring more to life.

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 were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll 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 youre 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.

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The Scientist II role is responsible for onboarding and overseeing multiple new technical transfer projects involving Drug Substance life cycles from development through clinical and commercial applications from both internal and external sending parties. This role focuses on process review optimization and implementation into GMP spaces. The position requires strong technical understanding to ensure robust efficient and compliant manufacturing processes for both internal development programs and external client transfers.

This position reports to the Manager of RNA Technical Operations and is part of the Technical Operations Department located in Fargo ND. This is an on-site role.

In this role you will have the opportunity to:

• Design execute and oversee working plans experiments and subsequent summary reports through all phases of the process (pre-clinical to clinical) in RNA work streams including associated technical writing and documentation equipment fit assessments and execution of confirmation batches that ensure scalable and reliable GMP Operations
• Serve as a technical leader leading and facilitating the onboarding of RNA technical transfers throughout the product life cycle
• Drive and lead cross functional initiatives training and communication within both GMP and non GMP spaces steering 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 while supporting value analysis/value engineering efforts
• Independently execute and lead technical writing robust change controls and quality event investigations
• Align with evolving business priorities by providing support to other critical functional areas as organizational needs and resource demands shift

The essential requirements of the job include:

• BS degree in biology molecular biology biochemistry chemistry or related discipline with 4 years of experience in biopharma drug substance or product or RNA/LNP-based manufacturing.
• MS degree in biology molecular biology biochemistry chemistry or related discipline with 2 years of experience in scale-up technical operations biopharma drug substance or product or RNA/LNP-based manufacturing.
• PhD in biology molecular biology biochemistry chemistry or related discipline with 1 years of experience in process development scale- up technical operations or RNA/LNP-based manufacturing.
• Experience in 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.

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

• Supporting mRNA/LNP programs across development stages with familiarity working within a regulated cGMP environment
• Working knowledge of current industry drug substance and drug product regulatory guidelines CMC expectations and regulatory filing contributions
• Use of automated systems for purification (e.g. AKTA systems KrosFlo systems) and reading automated method text instructions (e.g. Unicorn Repligen Recipe Editor)

Aldevrona Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits atDanaher Benefits Info

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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