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Scientist, Process Development (Formulation)

$109.2k - $174.6k

Moderna Therapeutics

The RoleModerna 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 DoDesign 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, documentation, technical writing, and communication skills.Ability to work effectively in a cross-functional development environment and manage multiple studies or priorities in parallel.At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.Here’s What You’ll Bring to the Table (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.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Competitive healthcare, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal OpportunitiesModerna 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. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. AccommodationsWe’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 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 for which the applicant has applied should contact the Accommodations team at View email address on us.fitly.work. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. -SummaryLocation: Norwood, Massachusetts; Technical DevelopmentType: Full time

Vacancy posted 14 days ago
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