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Engineer I, Process Development
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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. 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Engineer III, Systems Integration
ModernaTX, Inc., Norwood
The Role:Moderna is seeking an Engineer III for a position in the Systems Integration (SI) team, at the Moderna manufacturing site in Norwood, MA to drive the advancement of our next generation integrated hardware and digital systems. Reporting to the Principal Engineer, Applied Technologies, the individual in this role will focus on the design, development, and implementation of innovative integration solutions for various hardware and software systems, applications, and modules that optimize Moderna's operations and contribute to the production of messenger RNA based vaccines and therapeutics.The individual in this role with play a key role in the design, build, testing, deployment, and continuous improvement lifecycles of key integrated digital and hardware systems deployed at Moderna. This role will have an impact across our organization by driving cross functional collaboration between software developers, scientists, lab automation engineers, and other IT staff to ensure seamless integration and adoption of integrated technologies across the Research, Development, High-Throughput, Pre-Clinical, and GMP laboratories at Moderna.Here's What You'll Do:Design and implement solutions to integrate Moderna's diverse software and hardware systems, processes, and methodologies.Collaborate with software architects, developers, lab automation engineers, scientists across the organization to establish and document functional requirements and technical design descriptions for integrated systems.Establish release process and configuration management for integrated software solutions.Develop and maintain design documentation and process maps for integrated systems.Conduct system integration and interface testing.Monitor system performance post-integration and make necessary adjustments to ensure optimal performance.Support troubleshooting of integrated systems as needed.Prepare documentation and presentations for training end users on integration solutions.Coordinate with internal and external groups to identify appropriate software solutions to improve efficiencies in laboratory workflows.Keep up to date with the latest industry trends and technologies.Here is What You'll Bring to the Table:Minimum Qualifications:Bachelor's degree in systems engineering, Computer science, Information Systems, Bioengineering, Chemical Engineering, or a related field with no less than 5 years' experience in an industry setting.Proven experience as a Systems Integration Engineer or similar role preferably in healthcare industry.Experience with developing system analysis, risk analysis and/or vulnerability assessments.Experience with various programming languages, such as Java, Python, C#, or C++.Knowledge of databases, system architecture, and networking.Knowledge of REST and SOAP APIs, API gateways, and other API technologies.Knowledge of distributed messaging systems and protocols such as Apache Kafka, MQTTT etc.Knowledge of laboratory information management systems (LIMS), electronic lab notebooks (ELN), and other laboratory software.Familiarity with software development methodologies and the software development lifecycle (SDLC).Experience with using requirement, design and test management tools such as JAMA, code beamer, qTest etc.Familiarity with Atlassian tools for version control (Bitbucket) and issue management (Jira).Excellent written and oral communication.Preferred Qualifications:Master's degree in systems engineering, Computer science, Information Systems, Bioengineering, Chemical Engineering, or a related field with no less than 2 years' experience in an industry setting.Understanding of regulations and standards for medical device software (such as FDA regulations, ISO 13485, IEC 62304) is plus.Familiarity with laboratory operations and programming automated laboratory systems such as Hamilton, Tecan, Beckman Coulter, or Agilent is a plus.Experience with automation scheduling/control software (Green Button Go, Overlord, Momentum, Cellario etc.) is a plus.Experience with programming and operating robotic systems is a plus.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) -
Sr. Engineer I, Drug Product Development, Device and Combination Product
ModernaTX, Inc., Norwood
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) -
Sr. Engineer I, Drug Product Development
ModernaTX, Inc., Norwood
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) -
Sr. Engineer II, Drug Product Development
ModernaTX, Inc., Norwood
The Role:This position is part of Moderna's Drug Product Development team responsible for ensuring the translation of mRNA technology into successful dosage form and commercial product from a pharmaceutical sciences and engineering perspective. The incumbent will also provide technical leadership and mentoring to the Drug Product Development (DPD) group, helping to drive the execution of DP strategy and develop internal talent.From pre-clinical through commercialization, DPD is accountable for product image definition, formulation development, aseptic process development and characterization, container science, process scale up, and technology transfer through validation. Our team's goal is to develop, characterize, and implement robust clinical/commercial manufacturing processes for parenteral products.Here's What You'll Do:Lead matrixed Drug Product teams to advance formulation development, fill/finish process development, process characterization, technology transfer, and regulatory authoring of our mRNA portfolio candidates in development.Interface closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation.Interface with MS&T (US and International), External Manufacturing, Quality and Regulatory organizations to develop and execute on strategies for commercialization of late-stage programs.Collaborate with key stakeholders (Clinical Operations, Quality, Compliance, Analytical, MS&T, Regulatory etc.) to optimize our business processes maximizing agility and consistency.Design and execute detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and understand DPD processes.Provide technical mentorship to junior scientists/engineers in all aspects of parenteral drug product development and aseptic processing.Advance platform and functional initiatives through direct contributions and matrixed leadershipSupport authoring and review of regulatory submissions.Here's What You'll Bring to the Table:Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related disciplineMinimum of 4 years (PhD), 8 years (MS), 10 years (BS) industry experience in biopharmaceutical developmentStrong background in first principles modeling for drug product development, to enhance our pharmaceutical design and optimization processes.Experience serving on or leading cross-functional teams focused on biopharmaceutical developmentExperience in parenteral Drug Product development and commercialization, including working closely with external CMOs / CDMOs.Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving prioritiesPrior management and mentorship 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) -
Sr. Engineer II, Process Development
ModernaTX, Inc., Norwood
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) -
FM Approvals Engineer- Materials
FM Global, Norwood
FM Approvals is an international leader in third-party testing and certification services. We test property loss prevention products and services-for use in commercial and industrial facilities-to verify they meet rigorous loss prevention standards of quality, technical integrity and performance. How? By employing a worldwide certification process that's backed by scientific research and testing, and over a century of experience.The FM APPROVED mark is recognized and respected worldwide. Our certification instills confidence and commands respect in your marketplace.In this position you will plan, conduct and direct the evaluation and certification of property loss prevention products, with little or no supervision, in the area of building materials and assemblies. The testing will push the product's performance as it relates to wind, fire and other exposures in our world class, state of the art laboratories. You will help to increase the technical knowledge and provide solutions to the problems of property loss prevention and mitigation.Duties will include, but are not limited to, the development of proposals, project management, supervision of tests, documentation of results, preparation of written reports and other complex tasks associated with third party product certification.In addition, duties may include making presentations and providing representation to trade associations.The working environment includes both the office and laboratory.Overnight travel, to consult with customers, attend technical conferences and to conduct and monitor tests at test facilities, is typically less than 20%.BS in technical area + 3 years' experience or MS in technical area.Technical degree in civil, structural, environmental or mechanical engineering preferred.Knowledge of, and experience with, building materials, components, and assemblies is desired. A background in statics and/or material properties is beneficial.Successful candidate should have demonstrated project management skills, results analysis skills, superior written and verbal communication skills and computer proficiency with programs such as Word, Excel and Outlook.Professional registration and / or knowledge of FM Global Property Loss Prevention Datasheets is beneficial. Knowledge of FM Approvals Standards is preferred.Candidate must have the ability to read, write and speak English proficiently and the ability to understand and follow English instructions.Candidate must possess outstanding relationship management skills including:Exceptional customer service skillsExcellent communication skills (both orally and in writing)Active listening skills to understand the points being made when someone else is speaking and giving full attention to the speakerEffective speaking skills to convey direction, information and technical conceptsAbility to work effectively as a strong and supportive member of a teamDemonstrated skill in organizing work, setting priorities and planningWorking product evaluation environment involves fire, smoke, heat and the use of adhesives and binders.The hiring range for the engineer position is $85,800 to $123,300 USD. The final salary offer will vary based on geographic location, individual education, skills, and experience. The position is eligible to participate in FM Global's comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.FM Approvals is an Equal Opportunity Employer and is committed to attracting, developing, and retaining a diverse workforce.#LI-TA1