Data Engineer Salary in Norwood, MA

The Role:Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. Moderna is seeking a highly skilled and motivated Engineer II residing in Moderna's Technical Development organization in Norwood, MA. This role will support process development of Lipid Nanoparticles (LNPs) to enable our clinical and commercial pipeline. The applicant should have strong communication and collaboration skills, along with multiple examples of a strong technical background.The successful candidate must be able to work in a fast paced and highly dynamic environment, will have relevant academic and or industrial experience in drug delivery, process development or formulation development, and will be able to contribute to both process development and commercialization related activities. We seek applicants that are proactive, enthusiastic, and show a passion for their work. Applicants should have exceptional time management and communications skills with a strong attention to detail. Previous experience with chromatography, nanoparticle formulations, filtration technologies, mixing technologies, and/or tangential flow filtration is preferred. The position will support cross-functional teams across Technical Development, Manufacturing Sciences & Technology, Process Engineering, and Digital.Here's What You'll Do:Collaborate with cross-functional teams to collect data and inform experimental designDesign, execute and analyze experiments for existing and novel methods, processes, and equipment technologiesMaintain thorough documentation through electronic lab notebooks, technical reports, and technical presentationsDevelop robust, scalable, and well characterized unit operations and procedures for associated equipmentCommunicate findings to a wide audience in a timely and clear fashionMaintain positive relationships with internal and external partners to facilitate collaboration across functionsDeliver reproducible and impactful results under ambitious timelinesHere's What You'll Need (Basic Qualifications) Bachelor's degree in Systems Engineering, Bioengineering, Chemical Engineering, or a related engineering field with no less than 2 years experience in an industry setting.Knowledge of bioprocess engineering principles, processes, and analytical techniquesKnowledge of bioprocessing equipment and considerations for custom equipment designExperience in laboratory work and knowledge of appropriate laboratory hygieneKnowledge of statistical Design of Experiment (DoE) concepts and analysis of multivariate dataCreative/innovative/problem solverAbility to plan and execute experiments independentlyEffective communication skills and the ability to write detailed technical reportsAbility to effectively collaborate in a dynamic, cross-functional matrixed environmentStrong interpersonal skills with an eagerness to support colleagues throughout organizationAbility to thrive in a diverse and fast paced environmentDeep mechanical understanding and thirst for "how things work"Here's What You'll Bring to the Table (Preferred Qualifications)M.S. in Systems Engineering, Bioengineering, Chemical Engineering, or a related engineering field with 0-2 years experience in an industry setting.Prior co-op or internship experience in related industry is favorablePreferred: Familiarity with lipid nanoparticle process developmentPreferred: Experience with nanoparticle formulations and characterizationPreferred: Familiarity with nucleic acid drug process development (DNA, RNA, oligonucleotides)Preferred: Hands on experience with AKTA FPLC, Tangential flow filtration (TFF), and HPLC/UPLC instrumentationPreferred: Familiarity with common analytical techniques such as UV, Fluorescence, HPLC, LCMS, CE, GC, NMR, KF, IR, etc.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) -

The Role:Moderna is seeking an Engineer I to join the Process Development team to support development, scale up, transfer and commercialization of drug substances based on mRNA and lipid nanoparticle delivery technologies.Moderna is developing first-in-class mRNA-based vaccines and therapeutics. The mRNA is packaged into lipid nanoparticles for storage and delivery. The candidate will be focused on unit operations that are standard across the industry such as enzymatic reactions, normal and tangential flow filtration and chromatographic purification. The candidate will support commercial manufacturing processes and execute experiments to support deviation investigations and definition of appropriate process controls to increase process robustness.Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. The successful candidate will possess strong skills in designing and executing high quality bioprocess experiments using quality by design (QbD) and Design of Experiment (DoE) methods, and will collaborate through cross-functional matrix teams. The person in this role will have the opportunity to develop on-line analytics, process modelling and process investigation support. Results will be presented to broader groups allowing great exposure to CMC Strategy, Regulatory, MS&T, and Quality. Prior experience of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support process investigations, support technology transfer and provide Person-in-Plant (PiP) support for commercial batches. The position will be based out of Moderna's Norwood facility.Here's What You'll Do:Design, execute, and analyze experiments for existing and novel process modes using DoE and statistical modelingDefine the process, the critical parameters, and the design spaceCreate high throughput and automated experimental setupsLead experiments to confirm robust process performance across the control spaceCharacterize mRNA properties through collaboration with the analytical teamPrepare process descriptions, technical reports, and communicate findings internally and externally as appropriateCollect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups.Here's What You'll Bring to the Table:BS/MS degree in Bio/Chemical Engineering, Bio/Chemistry, Pharmaceutical Science, or related fieldHands on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operationsWorking knowledge of statistical design of experiments (DoE) and analysis of multivariate dataExperience with analytics and biophysical characterization of nanoparticles is a plusKnowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercializationDemonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes is a plusKnowledge of nucleic acid chemistry, lipid chemistry, and biology is a plusAbility to thrive in a diverse and fast paced environmentExcellent written and verbal communication skillsModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) -

The Role:This role will be responsible for ensuring continuous improvement and sustained compliance of GMP manufacturing process equipment located at the Moderna manufacturing facilities. This position will provide engineering support for utilities and HVAC to the campus, support in the execution of day-to-day operation, projects, and troubleshooting. Lead investigations relating to non-conformance events in partnership with Quality, IT, and Manufacturing. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.Proven problem-solving skills with a proactive, field-based approach for project and deviation management required. Ability to develop and drive continuous improvement initiatives is essential. Strong technical writing, problem solving skills, data analysis, and development and implementation of effective corrective and preventative action based on investigations is required.Here's What You'll Do:Provide direct engineering support and Subject Matter Expertise for plant and clean utility system (purified water system, WFI, autoclaves, process gasses, HVAC, etc.) This includes serving as the system owner for plant and clean utility systems.Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early-stage manufacturing processes.Lead and manage large sized, complex projects. Skills required to meet expectations of the role include high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. Manage project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.Candidate must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor, in addition to reviewing and guiding the work and performance of contractors.Collaborate with Quality functions to streamline processes and remove obstacles to allow for agile and compliant project execution.Own quality records such as Change Controls, Deviations, and CAPAs, related to plant utility systems, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.Here's What You'll Bring to the Table:Bachelor's degree EngineeringMinimum of 5 years relevant experience preferably as a Plant Engineer5 years of experience in a GxP biopharmaceutical operations environment preferred.Experience with plant and clean utility systems. Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. A comprehensive understanding of regulatory requirements and their applications in a cGMP environmentFamiliarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements.Experience interacting with representatives of regulatory agencies.Experience with facility, utility, systems, and equipment commissioning and qualification.Excellent written and oral English language skillsProject management experienceModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) #LI-NB1-

The Role:Moderna is seeking a highly skilled and motivated Senior Engineer to join our Drug Product Development (DPD) team in Norwood, MA, to support development of Moderna's device combination products. The primary role for this position will be to support drug product development activities including: device development, combination product development and packaging development. Specifically, the applicant will be responsible for Human Factors Engineering activities related to Moderna's combination products. Applicants should have relevant device engineering related experience in the pharmaceutical space. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.Here's What You'll Do:Lead human factors engineering activities on drug delivery device technology development and/or drug-device combination product programs. Be involved in problem solving and utilization of different strategies to support resolution of design, risk and regulatory challenges. Help establish and develop of human factors engineering strategies for drug delivery combination product. Ensure user needs are considered early and continuously throughout the design process. Manage and support the execution of early patient handling studies, identify and maintenance of user needs, conduct user related risk assessments and perform ethnographic analysis. Plan and support the execution of design validation studies. Author and/or provide oversight to human factors documents for device and combination product design history files. Interacting with external human factors vendors and senior leaders with regards to human factors strategy and implementation. Assist in platform device and packaging design and development identifying ways improve platform efficiency.Support the team by managing action plans and project plans to deliver short-, mid- and long-term development goals.Effectively communicate your work to the wider development team and stakeholders.Manage external vendors or partners as required to advance project milestones.Provide mentorship to junior scientists/engineers to develop appropriate internal capability.Maintain accountability for project success and results delivery.Support authoring and review of regulatory submissions and written responses.Here's What You'll Bring to the Table:BS (8+ years), MS (5+ years) or PhD in Human Factors/Systems/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry or related scientific disciplines with industry experience in small and/or large molecule combination drug product development.Exceptional laboratory skills and hands-on experience with aseptic liquid filling and handling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems.Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.Ability to perform data analysis using advanced statistical, including design of experiments (DoE) approaches leveraging statistical analysis softwareExperience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.Knowledge of GMP and GLP complianceModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) -

The Role:Moderna is seeking a highly skilled and motivated Scientist or Senior Engineer to join our Drug Product Development (DPD) team in Norwood, MA. To support Moderna's exciting pipeline of products, the DPD team works to develop, characterize, and implement robust clinical/commercial manufacturing processes. From pre-clinical through commercialization, DPD is accountable for product image definition, formulation development, process development, characterization and scale up as well as technology transfer. The focus of this role will be supporting product development and program progression through planning and executing studies in the laboratory, and the authoring of protocols, reports and regulatory documentation.Here's What You'll Do:Lead design, execution, documentation, and presentation of relevant experimentation to support Drug Product teams in advancing formulation development, fill/finish process development, container development, process characterization, technology transfer, and regulatory authoring of our mRNA portfolio candidates.Design and execute detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and troubleshoot specific unit operations.Author and review technical protocols, reports, product impact assessments, and regulatory sections as required in support of IND and marketing application submissionsEnable development of container closure options for Moderna clinical and commercial products by establishing test protocols and procedures as well as partnerships with external partners as required.Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projectsLead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables Support authoring and review of regulatory submissionsHere's What You'll Bring to the Table:BS (8+ years), MS (5+ years) or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry or related scientific disciplines with industry experience in small and/or large molecule parenteral drug product development.Exceptional laboratory skills and hands-on experience with aseptic liquid filling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems.Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.Ability to perform data analysis using advanced statistical, including design of experiments (DoE) approaches leveraging statistical analysis softwareExperience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.Knowledge of GMP and GLP complianceModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) -

The Role:We are currently seeking an experienced Senior Reliability Engineer who will be responsible for ensuring the reliability and sustainability of our manufacturing processes, equipment, and systems. This individual will have a strong understanding of reliability principles, predictive and preventive maintenance processes, and regulatory compliance in the pharmaceutical industry. Here's What You'll DoDevelop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts.Identify and manage asset reliability risks that could adversely affect plant or business operations.Apply data analysis techniques to predict, prevent, and eliminate possible operational interruptions.Develop engineering solutions to repetitive failures and other maintenance issues.Participate in the development of design and installation specifications and commissioning plans.Assess the need for replacement or upgrades of machinery.Ensure compliance with industry safety and design codes and standards.Collaborate with engineers and operational teams to understand the needs and requirements of the manufacturing process.Provide technical support to internal teams, troubleshoot equipment issues, and implement corrective actions.Ensure compliance with safety regulations and promote a culture of safety within the maintenance team.Additional duties as may be assigned from time to time.Here's What You'll Need: (BQs)AS or BS degree in a science/technical field, technical trade school and 5-8 years of relevant experience.Relevant experience as a reliability engineer.Here's What You'll Bring to the Table: (preferred)Preferred candidate will have worked in the biotech or pharmaceutical industryCertified Maintenance and Reliability Professional (CMRP)A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) #LI-NB1-

The RoleModerna is looking for a Senior Engineer I to join the Automated Systems Engineering team at our site in Norwood MA. The person in this role will work on the development, demonstration, and delivery of projects related to automated systems, help with documentation, and act as an SME in cross-functional teams. This role will have a significant impact across our organization by enabling cross-functional cooperation between teams that support our technical development and technical operations organizations. The successful candidate will be a key player during the design, build, test, deploy, and continuous improvement stages of key automated systems. This is a chance to be part of a progressive team and to make a difference in life-changing technologies.Here's What You'll Do:Collaborate with scientists to adapt bench top workflows to semi and fully automated workflows through requirement gathering, scripting, and deployment of liquid handlers and integrated automation platforms.Lead efforts to successfully deploy custom designed equipment for use in a pre-clinical, GLP, and GMP environments.Leverage your technical expertise to help shape our digital transformation by partnering with Digital and Systems Integration teams to integrate automation into our computational and data infrastructure.Prepare detailed development documents and provide hands-on training to operators allowing for successful handoff of automation platforms.Provide method development and troubleshooting support for existing automation workflows.Evaluate new automation to introduce cutting edge technologies to the team and wider organization.Follow engineering best practices to create robust lab automation infrastructure.Employ robust version control during method development.Act as a mentor for junior engineers, fostering a culture of learning and growth.Here's What You'll Need (Minimum Qualifications)BS in molecular biology, computer engineering/science, bioengineering or similar with 5+ years laboratory automation experience.Experience programming and developing with laboratory automation software/hardware and liquid handlers.Ability to routinely lift up to 15 lb. and occasionally up to 45 lb.Here's What You'll Bring to the Table (Preferred Qualifications)M.S. in STEM or a related field with 5+ years experience in a relevant industry or Phd with academic experience in a related field.Experience fully integrating automation hardware into data infrastructure, scheduling software, cloud infrastructure, and/or analytics software.Experience with 3rd party automation hardware such as decappers, centrifuges, dispensers, sealers/peelers, etc.Experience in DoE experimental design and method development.Experience with sample storage automation such as Liconic or Hamilton storage.Direct experience configuring and optimizing Hamilton STAR/Vantage automated liquid handling systems.Experience with LIMS systems and ELN such as Benchling and LabVantage.Experience with Bitbucket/GIT version control tools.Hands-on lab experience in one of the following areas: DNA assembly, plasmid creation and amplification, analytical assay development for DNA/RNA, and NGS.Experience with scheduling software such as Cellario, Green Button Go, Momentum, etc.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) #LI-KP1-

The RoleJoin us on a transformative journey as we revolutionize the biotech industry with the power of Moderna Mindsets. We are looking for a dynamic Senior Security Engineer to be a part of our Seattle team. This role will be pivotal in the selection, deployment, and upkeep of security tooling and infrastructure at Moderna, with a primary focus on Splunk. The ideal candidate will be agile, embodying an engineering mindset that resonates with the Moderna Mindsets.At Moderna, we value team collaboration, boldness in striving for excellence, constant curiosity, and a commitment to continual learning and improvement. We relentlessly seek the best talent in the industry.Here's What You'll DoAs a Senior Security Engineer, you will be part of the Cybersecurity Engineering team. Your responsibilities will include:Installing and maintaining Splunk infrastructure, gathering customer requirements, onboarding data, and assisting end users with search, dashboards, reports, and knowledge objects.Providing operations and maintenance support for a distributed Splunk environment.Creating, managing, and supporting automation solutions for Splunk deployment and orchestration in on-prem and cloud environments.Working with existing and custom Splunk applications and add-ons to fulfill customer needs.Onboarding data to Splunk from various sources and ensuring CIM compliance.Solving technical problems at the network, system, and application levels.Managing multiple assignments, changing priorities, and working independently with minimal supervision.Conducting architectural reviews of Splunk and related systems to assess effectiveness and propose optimal installation alternatives.Developing and managing comprehensive documentation, artifacts, procedures, and processes for optimal management of the Splunk infrastructure.Additional duties as may be assigned from time to timeHere's What You'll Need (Minimum Qualifications)A minimum of 8 years of experience in system administration, database administration, network engineering, software engineering, or software development, with a focus on Cybersecurity.5+ years of experience with Linux and Windows system administration.5+ years of experience with Splunk in distributed deployments.Experience with Splunk Enterprise Security or integration with other SIEM platforms.Proficiency in onboarding data using Splunk developed add-ons for Windows, Linux, and common third-party devices and applications.Proficiency in managing Splunk using the command-line interface and configuration files.Experience with scripting languages (e.g., Python, PowerShell) for automation and data manipulation.Here's What You'll Bring to the Table (Preferred Qualifications)Degree in Computer Science, Engineering, or a related field.Splunk Enterprise Certified Architect certification.Experience in networking and security troubleshooting (firewalls, routing, NAT, etc.).Experience with Vulnerability Management and related activities to drive risk reduction in large environments.Familiarity with the MITRE Adversarial Tactics, Techniques, and Common Knowledge or MITRE ATT&CK framework.Ability to adapt to a fast-paced and dynamic environment while managing multiple priorities.Strong written and oral communication skills, ability to work closely with multiple customers, manage expectations, and track engagement scope.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Under Washington State law, Moderna is required to provide a reasonable estimate of the salary range for the jobs covered by this description. Base compensation for these positions in Washington State range from $120,500 to $193,000. Actual salary determinations will take into account factors such as work location, prior education and experience, job-related knowledge, and demonstrated skills. Compensation decisions are made on the facts and circumstances of each case.In addition to base compensation Moderna employees are eligible for a comprehensive incentive compensation package including an annual cash bonus, new hire equity and an annual refresh, 401(k) match, competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts for medical and dependent care, Life, LTD, and STD insurance, family leave offerings, including at least 18 weeks of 100% paid parental leave, lifestyle spending account, adoption, surrogacy, and family-planning benefits, generous paid time off, including:• Vacation, sick time, and observed Company-wide holidays• Paid volunteer time to participate within your community• Discretionary winter holiday shut down • Paid 4-week sabbatical after 5 years, and every 3 years afterModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) #LI-KG1-

The Role:Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory, pilot and commercial scale process development, mRNA technology transfer to internal and external GMP production facilities and commercial production of mRNA therapies. Our team's goal is to implement and support robust commercial manufacturing processes. This Senior Engineer role requires close working relationships with Analytical Development, Manufacturing Sciences and Technology, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams. The incumbent will also help develop industry skills in high-performing junior team members both at the bench and in GMP manufacturing facilities.We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations (e.g. UF/DF, normal flow filtration, mixing systems, chromatography). The ideal candidate should have a strong background of supporting commercial operation of these unit operations with a focus on pro-active process improvements and optimization, effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations and implement appropriate controls to ensure robust commercial manufacturing. These skills should be complemented with a track record of excellent written and oral communication skills and experience operating within a Quality Management System. A history of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.Success in this role would be demonstrated by effective participation in process investigations, design and performance of experiments to identify/confirm associated root causes, followed by characterization and implementation of effective process changes to increase success in commercial production. This position bears the potential for significant growth in a dynamic organization.Here's What You'll Do:Provide subject matter expert (SME) expertise and representation in cross-functional process investigations for commercial processes.Support process investigations by active participation in root cause assessment exercises utilizing standard-industry toolsDesign and execute detailed experiments to assess and confirm root causes of process deviations and identify effective mitigation tools.Cross-functionally support establishment of appropriate CAPAs needed to improve robustness of commercial manufacturing processes.Identify opportunities for pro-active process improvements and optimization based on commercial performance data to improve robustness of commercial manufacturing process.Interface extensively in a matrixed environment with process development teams for process investigation support, assess new technologies, support on-going process characterization and post-approval changes.Support technology transfer and establishment of commercial process at new manufacturing sites and provide Person-in-plant (PiP) support as needed.Perform GMP activities with adherence to Quality Management System requirements.Mentor junior team members. Supervisory role may be included.Communicate clearly with program stakeholders, technical staff and external CMO partners.Generate high quality source documentation to support regulatory filings. Here's What You'll Bring to the Table:BS with a minimum of 10 years, or MS with a minimum of 8 years, or Ph.D with a minimum of 4 years of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changesExperience with mature quality management systems, deviation management, change controls and CAPA implementationExperience with lipid nanoparticle process development and mRNA process development is preferred.Experience in large molecule process development (late phase/commercial experience preferred)Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.Strong operational skills, interdependent project/timeline management capabilities.Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) -

The RoleModerna is seeking a Principal Systems Engineer, SAP EWM to primarily support our Individualized Neoantigen Therapy (INT) unit, which is our personalized cancer technology.Reporting to the Director of the Supply Chain systems, the Principal System Engineer will support the design, development, implementation and technical support of SAP EWM across a pharmaceutical manufacturing environment. This position will play a key role in supporting the Supply Chain strategy and will collaborate cross functionally to align data, processes and technology throughout the deployment of solutions.This is a great opportunity for someone who has always wanted to have a great impact on shaping the outcome of supply chain solutions in a fast-paced pharmaceutical environment.Here's What You'll DoServe as an SAP EWM and warehouse expert to the INT team. You will use your experience in defining, designing, and configuration across SAP Extended Warehouse Management. Partner with the EWM Principal System Engineer in US to define the best design and architecture of EWM.Be the key point of contact for INT business and site for direct purchasing & warehousing departments.Support and enhance the actual EWM solution.Support data analysis, program debugging and report writing.Write business design documents, functional specs, test scripts, SOPs.Support SAP projects to drive continuous improvement for logistics activities.Perform business analysis and SAP ERP S/4 system support of the supply chain units in a fast-paced clinical and commercial drugs manufacturing environment.Here's What You'll Need (Minimum Qualifications)8+ years of experience in the design, configuration and testing of solutions across an SAP system.Specific experience in the following submodulesEWM and/or WM / HUM SAP modulesInventory management (IM)Direct Purchasing (MM)Logistics execution (LG / LE) - Intra and Intercompany stock transfersPP-PI and QMIntegration with MES and SAP EWMMultiple years of experience engaging with business partners.Experience with proposing functional solutions to developers when writing functional specs.Familiarity of SAP S/4 is a plus.Experience in an FDA regulated environment such as Pharma/Medical device.Experience with drug product serialization and serialization software is a plus.Here's What You'll Bring to the Table (Preferred Qualifications)5+ years of experience working in a GXP/Pharma/Life Science organizationExperience delivering projects using Agile MethodologySAP S/4HANA experienceAbility to manage multiple request and projects in a fast-paced environment. SAP certification preferred.Be self-driven, willing to collaborate, think creatively, and drive tasks to completion with minimal oversight.Project management skills with the ability to prioritize and multi-task activities in a dynamic, fast-paced environment and simultaneously organize work across multiple projects.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 [email protected]. (EEO/AAP Employer) #LI-KG1-