Scientist, Process Development (Formulation)

Role Overview Moderna is seeking a highly skilled and motivated individual to develop stable, fit‑for‑purpose enzyme formulations for DNA template manufacturing to support our mRNA medicines portfolio. This laboratory‑based role will design and execute formulation, stability, compatibility, and use‑condition studies for enzymes used in DNA manufacturing workflows, translating enzyme performance needs into practical formulation compositions, storage conditions, and handling instructions that preserve activity, consistency, and process performance. Responsibilities 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 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. 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, documentation, technical writing, and communication skills. Ability to work effectively in a cross‑functional development environment and manage multiple studies or priorities in parallel. U.S. work authorization required; no immigration sponsorship available. Preferred Qualifications Experience with enzymes used in DNA or nucleic acid manufacturing (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 preparing technical packages for technology transfer, manufacturing troubleshooting, regulatory‑supporting documentation, or phase‑appropriate CMC deliverables. Familiarity with container‑closure systems, single‑use materials, adsorption risk, extractables/leachables considerations, or material compatibility assessments. Knowledge of GMP, GLP, or phase‑appropriate development expectations for biologics, enzymes, or critical raw materials used in manufacturing. Pay & Benefits Salary range: $109,200.00 – $174,600.00. Best‑in‑class healthcare coverage, voluntary benefit programs, holistic well‑being resources, family planning benefits, generous paid time off, savings and investment opportunities, and location‑specific perks. Equal Opportunity & Accommodations Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Applications are considered regardless of criminal histories, consistent with legal requirements. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position should contact the Accommodations team at View email address on click.appcast.io. #J-18808-Ljbffr BioSpace