Principal Scientist - PERM

Orna Therapeutics, Inc. is seeking a Principal Scientist.

500 Forge Road, Watertown, MA 02472.

• Lead the function of bioanalytical assessment and the characterization of humoral and cellular immunogenicity of novel RNA Lipid Nanoparticle (LNP) therapeutics for the treatment of cancer, autoimmune, and other severe diseases such as multiple myeloma, B‑cell lymphoma, and systemic lupus erythematosus.
• Function as a Key Opinion Leader (KOL) in immunogenicity assessment of LNP therapeutics within the biotech industry.
• Lead and manage RNA LNP drug nonclinical development projects, including planning scope, timelines, budget and execution.
• Direct the execution of Pharmacodynamic (PD) assays and immunogenicity assays.
• Design and oversee the execution of phase‑appropriate preclinical and clinical bioanalytical strategies, including quantitation and characterization of biomarkers using ligand binding assay and immunogenicity evaluations (cytokine, anti‑CAR antibody and anti‑PEG antibody) of mRNA‑LNP therapeutics.
• Provide data for correlation of drug efficacy, toxicity, prediction of human dose with maximal benefit‑to‑risk ratio, and tests such as pharmacokinetic (PK), anti‑drug antibody (ADA), cytokine, and biomarker assays.
• Ensure timely generation of critical chemical and biological reagents for various bioanalytical assays and qualify the reagents through chemical and physical properties including their size, stability, purity, sequence and bio‑reactivity.
• Direct, supervise, and mentor junior scientists in test procedures such as sample extraction and measurement by bDNA, ELISA, MSD, Luminex and flow cytometry and data interpretation.

• Master’s degree in Pharmaceutical Sciences or a related field, plus 5 years of industry experience in nucleic acid therapeutic research and development, including 2 years of experience in RNA therapeutic development.
• 5 years of experience developing bioanalytical methods to measure drugs and biomarkers.
• 2 years of experience in design and execution of drug immunogenicity evaluation strategies including cytokine and anti‑drug antibodies.
• 2 years of experience in CRO management for sample analysis.
• 1 year of experience in generation and qualification of critical reagents.

Salary: $151,674 to $182,065 per year.

Interested candidates should click on “Apply Now” to submit an application.