Scientist, Process Development (Formulation)

The Role Moderna is seeking a highly skilled and motivated Individual to develop stable, fit-for-purpose enzyme formulations for DNA template manufacturing in support of Moderna’s mRNA medicines portfolio. This lab-based role will design and execute formulation, stability, compatibility, and use-condition studies for enzymes used in DNA manufacturing workflows. The work will translate enzyme performance needs into practical formulation compositions, storage conditions, and handling instructions that preserve activity, consistency, and process performance. The Candidate will work most closely with enzyme process development and analytical development to define formulation requirements, measure enzyme performance, and troubleshoot stability or activity losses. As formulations mature, this individual will provide technical inputs to tech transfer formulation process into manufacturing with clear material attributes, handling controls, and documentation. Here’s What You’ll Do 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. 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 that are 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 as needed. Stay current with advances in protein/enzyme formulation, biologics stability, excipient selection, and high-throughput or miniaturized formulation screening approaches. Here’s What You’ll Need (Basic Qualifications) 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 ... (truncated, view full listing at source)