mRNA–LNP Process Development Scientist / Assoc. Scientist

mRNA–LNP Process Development Scientist / Assoc. Scientist

About Kernal Biologics, Inc. 

Kernal Bio is a venture-backed therapeutics company engineering cells inside the body using AI-designed, selective mRNA and targeted LNP technology. By developing in vivo CAR-T therapies, Kernal Bio is advancing precision treatments for autoimmune diseases and blood cancers. The company was founded by experts from MIT, Harvard, Merck, and BMS, and its leadership team brings a track record of three FDA-approved therapies and over 120 patents. Based in Boston, the company is backed by Hummingbird Ventures, Amgen, Lilly, HBM, ARPA-H, and NVIDIA. Kernal Bio is transforming the future of cell therapy design and delivery.

Job Summary:

Kernal Bio seeks motivated mRNA-LNP Process Development Scientists to advance its mRNA 2.0 therapeutic platform. Responsibilities include developing and manufacturing mRNA-LNP therapeutics, conducting analytical characterization, and performing in vitro and in vivo preclinical testing. Candidates must have expertise in mRNA chemistry, biology workflows, and wet-lab methods.

Responsibilities:

• Development, optimization, and troubleshooting of LNP/mRNA manufacturing processes at various scales.
• Characterize LNP formulations and components using Dynamic Light Scattering, Ribogreen, HPLC, etc.
• Develop new assays or detailed investigations of specific LNP attributes as required.
• Screen final formulation buffers and excipients to improve the long-term stability of LNPs

• Manufacture routine mRNA products for preclinical studies
• Optimize and scale up  mRNA-LNP manufacturing capability 
• Develop scalable strategies for downstream product purification 
• Carry out process development studies using the design-of-experiments approach.
• Perform routine analytical and bioanalytical tasks such as HPLC, qPCR, ELISA, fragment analysis, mammalian cell culture, transfection, fluorescence, and flow cytometry
• Help with in vivo studies in rodents for quality validation 

• Maintain up-to-date records and prepare internal reports.
• Analyze, summarize, and present experimental results to team members and management.
• Maintain stocks and supplies for the operation of the Process Development Functions.
• Participate in technology transfer activities related to manufacturing processes and/or analytical methods to external partner programs.
• Contribute to technical discussions & intellectual property related to the development and application of Kernal’s proprietary technologies

Requirements:

• BS/MS and PhD in Chemical Engineering, Bioengineering, Biomedical Engineering, Chemistry, Biology, Molecular Biology, or a similar field
• 2-5 years of academic and industry experience in process development in the context of mRNA, lipid nanoparticles, polymeric nanoparticles, or similar.
• Experience in manufacturing mRNA IVT reactions and mRNA purification
• Experience in manufacturing LNPs using Microfluidics, T-mixer, or other inline mixers.
• Experience with tangential flow filtration (TFF) and sterile filtration.
• Proficiency with related LNP/mRNA analytical techniques (e.g. plate-based fluorescence assays, HPLC, LC/MS)
• Familiarity with ELN and GraphPad Prism.
• Preferred: Experience with bioprocess engineering principles, process modeling, and Design of Experiment (DoE) statistical tools.
• Preferred: Experience with tech transfer to GMP manufacturing.
• Attention to detail, ability to multi-task, and complete deliverables within timelines.
• Strong written and verbal communication skills.
• Adaptability and enthusiasm for new challenges and a passion for learning in a fast-paced startup setting.
• Ability to work independently while effectively interacting and collaborating in a team environment.

Benefits:

• Competitive 401(k)   
• Highly competitive healthcare coverage (PP