Scientist I, RNA

Aldevron; Fargo (ND); On-site; USD 70,000 - 90,000; Full time

Job summary

Aldevron in Fargo, ND is seeking a Scientist I to onboard RNA technical transfers from development through clinical and commercial stages. You will help ensure robust, compliant GMP manufacturing processes and work with internal teams to enable on-time, right-first-time delivery.

Reporting to the Manager of RNA Technical Operations, this on-site role emphasizes hands-on process review, technical writing, and data analysis in support of drug substance programs and external client transfers.

Qualifications

• BS degree with 2+ years in biopharma/drug substance or RNA manufacturing.
• MS degree with 1+ year in scale-up or technical operations in biopharma.
• PhD with 0+ years in process development or RNA/LNP manufacturing.

Responsibilities

• Assist in execution of working plans or studies in RNA work streams, including technical writing and documentation.
• Execute and aid in onboarding of RNA technical transfers through product life cycle.
• Work collaboratively across manufacturing, quality, and validation as a SME to support on-time delivery and right-first-time metrics.
• Execute change controls and assist in quality investigations and technical writing with oversight.
• Align with evolving business priorities by supporting other critical functional areas as needed.

Skills

RNA manufacturing

Technical operations

Data analysis

Technical writing

GMP operations

Education

BS degree in chemical engineering / bioengineering / biology / molecular biology / biochemistry / chemistry

MS degree in chemical engineering / bioengineering / biology / molecular biology / biochemistry / chemistry

PhD in chemical engineering / bioengineering / biology / molecular biology / biochemistry / chemistry

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 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 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.

Learn about the Danaher Business System which makes everything possible.

The Scientist I role is responsible for onboarding new technical transfer activities 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 and implementation into GMP spaces. The position requires technical understanding to ensure robust 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:

• Assist in the execution of working plans or studies with oversight and guidance through all phases of the process (pre-clinical to clinical) in RNA work streams, including associated technical writing and documentation, and execution of confirmation batches that ensure scalable and reliable GMP Operations
• Execute and aid in the onboarding of RNA technical transfers through product life cycle
• Work collaboratively and cross functionally to achieve goals within manufacturing, quality, and validation as a subject matter expert (SME) to provide technical support to internal business and operations teams to support on time delivery and right first time metrics
• Execute change controls and aid in quality event investigations and technical writing with oversight
• 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 chemical engineering, bioengineering, biology, molecular biology, biochemistry, chemistry, or related discipline with 2+ years of experience in biopharma, drug substance or product, or RNA/LNP-based manufacturing.
• MS degree in chemical engineering, bioengineering, biology, molecular biology, biochemistry, chemistry, or related discipline with 1+ years of experience in scale-up, technical operations, biopharma, drug substance or product, or RNA/LNP-based manufacturing.
• PhD in chemical engineering, bioengineering, biology, molecular biology, biochemistry, chemistry, or related discipline with 0+ years of experience in process development, scale-up, technical operations, or RNA/LNP-based manufacturing.
• Experience in RNA manufacturing, experimental design, and data analysis preferred.
• Basic knowledge in biologics downstream bioprocessing and equipment.

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

• Supporting RNA/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)

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.

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.

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].