Scientist, Process Development (Formulation)

Job Title: Scientist, Process Development (Formulation)

About 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. This individual will work 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 processes into manufacturing with clear material attributes, handling controls, and documentation.

Key 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.
• Stay current with advances in protein/enzyme formulation, biologics stability, excipient selection, and high-throughput or miniaturized formulation screening approaches.

Requirements & Tech Stack

• 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.

Preferred Qualifications

• 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 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.

Note: Candidates must already hold work authorization in the US and be able to maintain that status without the need for future sponsorship.

Note: This position may involve access to technology or data subject to U.S. export control laws. Employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.