Scientist II, RNA
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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)
Responsibilities
- 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
Benefits
- health care program
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
