Scientist, Process Development; Formulation

Role Overview

The role is focused on developing stable, fit‑for‑purpose enzyme formulations for DNA template manufacturing in support of Moderna’s mRNA medicines portfolio.

• Design and execute enzyme formulation studies to identify buffer, pH, ionic strength, stabilizer, surfactant, cryoprotectant, concentration, and storage conditions for enzymes used in DNA template manufacturing.
• Develop stability study designs that evaluate enzyme activity, purity, degradation, aggregation, adsorption, concentration recovery, and functional performance under process‑relevant conditions.
• Assess formulation robustness during freeze/thaw, hold time, dilution, mixing, temperature exposure, agitation, contact‑material exposure, and other handling conditions relevant to development and manufacturing.
• Use enzyme activity assays, biochemical/biophysical characterization, and DNA process performance readouts to connect formulation attributes to manufacturing outcomes.
• Identify degradation or performance‑loss mechanisms and propose formulation or handling changes based on scientific rationale and experimental data.
• Apply DOE, risk‑based study design, and fit‑for‑purpose scale‑down models to accelerate formulation selection and define practical operating ranges.
• Partner with analytical development to select or establish methods suitable for enzyme formulation screening, stability assessment, and use‑condition characterization.
• Partner with DNA process development to ensure enzyme formulations meet process needs for performance, robustness, usability, and manufacturability.
• Prepare clear protocols, technical reports, data summaries, handling recommendations, and transfer‑ready documentation.
• Support implementation of selected enzyme formulations by providing technical rationale, troubleshooting guidance, and material/control strategy inputs to manufacturing sciences, CMC, and Quality partners.
• Stay current with advances in protein/enzyme formulation, biologics stability, excipient selection, and high‑throughput or miniaturized formulation screening approaches.

• PhD in Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, or a related discipline; or MS with 5+ years or BS with 8+ years of relevant industry experience.
• Hands‑on experience in protein, enzyme, biologics, or drug product formulation development.
• Strong understanding of protein/enzyme stability and degradation mechanisms, including aggregation, oxidation, deamidation, hydrolysis, precipitation, adsorption, thermal stress, freeze/thaw stress, and interfacial stress.
• Experience designing and executing formulation screens, excipient compatibility studies, forced degradation studies, accelerated stability studies, hold‑time studies, or use‑condition studies.
• Experience using analytical, biochemical, biophysical, or functional assays to characterize protein or enzyme formulations and interpret results in the context of performance.
• Ability to analyze data, identify formulation risks, troubleshoot technical issues, and recommend next studies or formulation changes.
• Strong laboratory execution, documentation, technical writing, and communication skills.
• Ability to work effectively in a cross‑functional development environment and manage multiple studies or priorities in parallel.

• Experience with enzymes used in DNA or nucleic acid manufacturing, such as polymerases, restriction enzymes, nucleases, ligases, phosphatases, or other DNA‑modifying enzymes.
• Experience with DNA template production, plasmid DNA, synthetic DNA, mRNA, RNA, LNP, oligonucleotide, vaccine, or other nucleic‑acid‑based platforms.
• Experience developing liquid, frozen, refrigerated, or lyophilized protein/enzyme formulations and defining fit‑for‑purpose storage and handling requirements.
• Experience with characterization methods such as enzyme activity assays, chromatography, electrophoresis or CE, UV/Vis, DLS, DSC/DSF, osmolality, pH, subvisible particle analysis, or related stability‑indicating methods.
• Experience with high‑throughput formulation screening, automation, miniaturized scale‑down models, statistical analysis, or DOE.
• Experience…