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The Engineer II, LNP Process Development leads technology transfer activities across Drug Substance and Drug Product life cycles—from late‑stage process development through clinical and commercial manufacturing. This role drives process design, scale‑up, and optimization with a focus on LNP Drug Product delivery systems. The position applies strong technical skills and independent problem‑solving to help ensure manufacturing processes are robust, efficient, and compliant for both internal development programs and external client transfers.

This position reports to the Manager of LNP 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:

• Drive technical activities that support robust, compliant processes aligned with client expectations and regulatory requirements.

• Execute and help shape process design, evaluation, and optimization work for LNP‑based Drug Product processes, including technical documentation, equipment fit assessments, and execution of studies that support scalable and reliable GMP operations.

• Provide hands‑on technical support during manufacturing campaigns, assisting with troubleshooting, deviation management, and cross‑functional alignment to maintain strong process understanding through final product release.

• Develop growing subject‑matter expertise in LNP formulation science, process development, and technology transfer, and provide clear, dependable technical input during client discussions and internal reviews. Inform technical and operational decisions by contributing data‑driven insights to evaluations of new technologies, capital investments, and process improvements.

• Support development of junior team members by sharing technical learnings, participating in cross‑functional efforts, and promoting best practices in scientific and operational execution.

The essential requirements of the job include:

• BS degree in Chemical Engineering, Bioengineering, Chemistry, or a related field with 4+ years of relevant industry experience in biopharma, drug product development, or LNP/mRNA‑based manufacturing, supporting process development, scale‑up, or GMP technical operations. OR

• MS degree in a relevant scientific or engineering discipline with 2+ years of experience supporting process development, scale‑up, or GMP technical operations. OR

• PhD in a related field with 1+ year of hands‑on experience in LNP formulation, RNA therapeutics, or parenteral drug product manufacturing.

• Foundational experience with LNP formulation, microfluidics‑based mixing, and technology transfer, including involvement in GMP batch support, process troubleshooting, deviation investigations, or data analysis.

• Effective cross‑functional communication and collaboration skills, including partnering with Manufacturing, QA, QC, MSAT, and client‑facing teams, preparing technical documentation, presenting data, and supporting data‑driven decisions and continuous improvement.

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

• Supporting mRNA or LNP development and scale‑up activities, including exposure to CMC expectations or regulatory‑relevant documentation.

• Working with formulation or microfluidic mixing systems and helping adapt or troubleshoot these platforms during process development or tech transfer.

• Performing or interpreting routine analytical characterization to assess LNP or drug product quality and contribute to data‑driven process decisions.

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