Scientist II, RNA

Danaher Corporation; Fargo (ND); On-site; USD 90,000 - 130,000; Full time

Job summary

Aldevron, a Danaher operating company, seeks a Scientist II to onboard and oversee multiple RNA technical transfer projects from development through clinical and commercial applications in Fargo, ND. This on-site role focuses on process review, optimization and compliant GMP operations.

You will lead technical writing, change controls, and collaborate with GMP/non-GMP teams to drive on-time delivery and right-first-time results in a dynamic biotech environment.

Qualifications

• BS/MS/PhD with relevant experience in biopharma, drug substance, or RNA/LNP manufacturing.
• Experience in scale-up, technical operations, or process development in a cGMP environment.
• Ability to lead technical transfers and manage multiple projects.

Responsibilities

• Design, execute and oversee plans, experiments and summaries through pre-clinical to clinical RNA work streams.
• Lead onboarding of RNA technical transfers across the product life cycle.
• Drive cross-functional initiatives and provide SME support to ensure on-time, right-first-time delivery.
• Lead technical writing, robust change controls and investigations.
• Support evolving business priorities across functional areas.

Skills

Biology knowledge

RNA/LNP manufacturing

GMP operations

Data analysis

Technical transfer

Education

BS in biology / related

MS in biology / related

PhD in biology / related

Tools

AKTA systems

KrosFlo systems

Unicorn

Repligen Recipe Editor

Job description

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 Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and 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 life—impacting 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 potential—one discovery at a time.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

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)

Aldevron , a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home)

Join our winning team today. Together, we’ll accelerate the real‑life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

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.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].