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Engineering Project Manager Salary in Norwood, MA

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Engineer III, System Owner, Small Scale
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The Role:The Process Engineer III will be responsible for ensuring operability and reliability of GMP manufacturing process equipment located at the Moderna manufacturing facility in Norwood, MA. This individual will work with closely with Facilities and equipment End Users to investigate and troubleshoot issues related to process equipment. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.Here's What You'll Do:Provide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, Reaction Vessels, Temperature Control Units, Fermenters, Mixers, etc...)Serve as the Engineering System Owner for process equipment, including the development and improvement of maintenance procedures, spare parts lists, and training for technicians and manufacturing operators.Provide technical support and execution of EHS policies, procedures, and initiatives.Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early and late-stage manufacturing processes.Drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. 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Provide input into assessing change controls, and continuous improvement initiatives.Here's What You'll Bring to the Table:Minimum Education Requirement: A bachelor's degree in Chemical or Mechanical EngineeringMinimum of 5 years of relevant experience as a Process Engineer.Minimum of 2 years of experience in a GxP environment preferred.Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc)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.Demonstrated ability to manage own time and deliver to program timelines.Proven ability to multitask.Self-directed with effective analytical and problem-solving skills. 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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) -
Plant Engineer III
ModernaTX, Inc., Norwood
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-
Sr. Manager, Technical Development, Raw Materials
ModernaTX, Inc., Norwood
The RoleIn this role, you will be accountable for defining the CMC lifecycle road map and guiding the raw materials through key lifecycle milestones such as definition of specifications, process and method development, and qualification for custom small molecules. The Senior Manager will lead a cross functional team of scientists and engineers while acting as a single point of contact for all technical support activities and product lifecycle plans. This individual will play a key role in ensuring alignment between key stakeholders within the Technical Development and wider CMC organization while driving activities to ensure the availability, quality, and compliance of raw materials used in the manufacturing of Moderna's mRNA therapeutics and vaccines.Here's What You'll DoLead the end-to-end product lifecycle management of custom/critical raw materials, including specification development, supplier selection, and qualification while ensuring alignment with regulatory guidelines and industry standards.Collaborate with cross-functional teams, including Process Chemistry, Analytical Development, Quality Assurance, Operations, Regulatory Affairs and Process Development to develop product requirements and align specifications with program needs.Coordinate cross functional technical investigations and problem-solving activities for critical raw materials used across multiple commercial, clinical, and development programs.Ensure alignment between CMC long range plan demand and supply planner projections.Stay current with industry trends and regulatory requirements related to raw materials, providing guidance and recommendations to internal stakeholders.Lead a cross-functional team of scientists and engineers, providing mentorship, guidance, and performance feedback to foster a high-performing and collaborative work environment.Act as an integrator to connect technical SMEs with operational, quality, and drug product lifecycle teams, providing technical support and guidance to internal and external stakeholders.Additional duties as may be assigned from time to time.Here's What You'll Need (Minimum Qualifications)BS. in a scientific discipline (Chemistry, Biochemistry, Chemical Engineering, or related field) with a minimum of 8 years or MS with a minimum of 6 years of relevant experience in the biopharmaceutical industry.Here's What You'll Bring to the Table (Preferred Qualifications)Experience in the qualification and CMC lifecycle of custom raw materials, including the development of specifications, supplier selection, and ongoing performance monitoring.Experience with custom lipid, enzyme, plasmid, and/or nucleotide manufacturing is desirable.Familiarity with current Good Manufacturing Practices (cGMP) and regulatory requirements for raw materials in the biopharmaceutical industry.Proven track record of successfully leading cross-functional teams and strong project or program management experience.Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders at all levels.Strong problem-solving and risk-based decision-making abilities, with a strategic mindset and attention to detail.Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously.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) -
Principal Engineer, Filling Equipment
ModernaTX, Inc., Norwood
The Role:The Principal Engineer for DP Filling Equipment will report to the Director of DP Process Engineering, serving as the subject matter expert (SME) for the Filling and closing Drug Product Manufacturing Equipment at Moderna. The incumbent will lead DP primary filling, containment and sterile operations engineering discipline for Capital Projects throughout Moderna's global footprint for both Clinical and Commercial supply operations.The role also involves providing guidance to existing manufacturing facilities, including contract manufacturing sites. The ideal candidate should possess knowledge of regulatory and performance requirements for process equipment used in the sterile filling and closing of pharmaceutical drug products.The Filling Equipment Engineer will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle, leading projects in the Fill and Finish Engineering discipline. This role requires the ability to manage multiple contractors and a portfolio of technical projects simultaneously.This role is based in Norwood, MA and reports to the Director of DP Process Engineering. Travel to support global manufacturing expansion could be up to 30% at critical project phases.Here's What You'll Do:Develop specifications for filling and closing equipment.Lead Front End Planning (FEP) activities for the filling and closing equipment scope on capital projects and programs.Contribute to/perform equipment vendor selection and assessments.Provide input to user requirements, design specifications, process parameters, and FMEA assessments.Own filling and closing best practices and functional standards that enable global standardization of process, equipment, and systems.Translate the business needs of the company into engineering solutions.Serve as a Subject Matter Expert in primary packaging.Independently execute, and direct others in the execution of, the design of processes and equipment.Identify new technologies for filling and closing primary packaging equipment.Drive results by owning and completing capital projects.Participate in all phases of engineering projects related to process equipment.Troubleshoot equipment to determine root cause of failure modes.Drive development of Engineering Turnover Packages.Here's What You'll Bring to the Table:A Bachelor's degree in Electrical, Mechanical, or relevant engineering disciplineMinimum of 10 years experience as an EngineerMinimum 10 years of experience in a GMP environmentA technical and regulatory background in DP filling and closing equipment in pharmaceutical industry.Experience in large capital/expansion programs with direct design responsibilityExperience with a Thermoforming, Heat Sealing, Plunger Insertion Side Load and Top Load Cartoning, Flexible Packaging Line Design, Vision Inspection Systems, Serialization and on-line barcode printing and verification and coding,Working knowledge of Aseptic Filling, Freeze Drying, Automatic Inspection and Clinical Packaging Operations would be preferred.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 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 for complex problems. Familiarity 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.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-
Director, Project Controls
ModernaTX, Inc., Norwood
The RoleIn this role, you will Reporting to the Senior Director, Capital Projects and Project Controls, the Director - Project Controls will be responsible for establishing and implementing project controls methodologies across the company including Front End project execution strategy development, estimating, scheduling, cost control, project buyout and logistics for all Moderna Capital Projects Worldwide.Here's What You'll DoThe Director - Project Controls will be jointly responsible with the Capital Projects Team for managing Moderna's annual spend in Capital, Construction and Engineering across all global functions in the organization. The role will ensure the projects are planned strategically, sequenced, budgeted and executed in an orderly compliant manner, ensuring that value from allocated funds are maximized. This includes implementing and managing the following key activities:Capital Planning:Collaborate with finance, operations and other internal stake holder to develop long range plansEstablish and implement means and methods to ensure reliable and accurate quarterly and annual forecasting of cashflowProject Execution StrategyEstablishing Project execution strategy, timeline and budget risk assessment, development of project buyout strategy and setting up project support teamPortfolio ManagementEstablish and implement means and methods to ensure reliable and accurate reporting on portfolio and project statusPartner with Project Managers to provide necessary levels of visibility to management's attentionEstimating & Benchmarking :Establish and implement estimating and benchmarking means and methodsPrepare initial estimates for mission critical projectsPartner with project management teams to ensure accurate estimateReview estimates prior to funding approvals to ensure accuracyScheduling & Progress MeasurementEstablish and implement scheduling and progress measurement means and methodsPrepare initial schedules for mission critical projectsPartner with project management teams to ensure accurate schedulesReview schedules prior to funding approvals to ensure accuracyCost Management:Establish and implement means and methods for project Cost ManagementEnsure timely review of project progress, invoice management and paymentEstablish and implement means and methods to ensure proper change and vendor managementContract Management:Partner with sourcing and project management to ensure appropriate contract types and execution strategies are deployedPartner with sourcing and project management to establish means and methods to prepare and review RFP templates, bids and ProposalFinancial and Schedule Risk Management:Establish and implement means and methods to develop and track, and mitigate cost and schedule risksAdditional duties as may be assigned from time to timeTeam ManagementAssist in accomplishing department objectives by managing both FTE& contract staff; planning and evaluating department activitiesAssist in maintaining staff by recruiting, selecting, orienting, and training FTE & contract support personnelAssist in accomplishing staff results by communicating job expectations; planning, monitoring, and appraising job results to FTE & contract support personnel.Coaches, counsels, and disciplines both FTE's and contract support personnelDevelops, coordinates, and enforces departmental systems, policies, procedures, and productivity standards.Provide Oversight of accuracy, quality control and cadence of project controls cost deliverables by FTE's and contract support personnelHere's What You'll Need (Minimum Qualifications)10-15 years of experience in a delivery of Capital, Construction and Engineering with at least 5 years specifically in the biopharmaceutical industry.10+ years of management experience in the areas of Project Controls or Capita Project execution around multiple geographiesBachelor's degree required. BA/BS in a Technical discipline desired; Master's degree (MBA, MS) preferred.Proficient-level skills in the following key competencies/skills: communications, project management, relationship management, estimating, scheduling, financial acumen, cost and financial management, aptitude for technology, results-focus, professionalism, and success in a matrixed environment.A proven track record of project delivery on fast track, highly technical projectsA proven track record of supporting a complex major capital programAbility to work in a highly metric-driven environment.A deep desire to be a key part of building a world-class Engineering function.Ability to lead through service, recommend execution strategies, and deliver business results.Strong collaboration and communications skills required to address and resolve issues in a matrixed environment and with the Finance function.Excellent negotiation, organizational, interpersonal and problem-solving skills Demonstrates strategic enterprise thinking, finding innovative ways to deliver results, and build trustMust possess outstanding communication, analytical, and problem-solving skills and the ability to work with enterprise-wide information systemsAbility 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.Ability to make effective oral presentations and work as part of a team.Here's What You'll Bring to the Table (Preferred Qualifications)Bachelor's degree required. BA/BS in a Technical discipline desired; Master's degree (MBA, MS) preferred.Deep understanding of Capital Project Controls - both Cost and Schedule elements, and associated elements of cost estimating, benchmarking, capturing actuals, monthly and annual forecasting, and tools such as SAP, Primavera P6, Microsoft Project, Oracle Unifier, Procore, Advanced Excel, Smartsheet and other Project Management/Cost Management tools.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-
Sr. Manager, Regulatory Science, CMC
ModernaTX, Inc., Norwood
The Role:The Sr. Manager, Global Regulatory CMC will be support regulatory CMC activities for one or more programs. The Sr. Manager will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy. The Sr. Manager will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients and will be based at the Norwood, MA site.Here's What You'll Do:Support development of CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risksProvide guidance for regulatory CMC aspects of product development projectsReview documents for submission-readiness, to ensure that all submissions conform to health authority guidelinesContribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissionsSupport develop regulatory processes and procedures to support CMC components of regulatory submissionsSupport the creation and maintenance of CMC submission templatesProvides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controlsProvides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programsHere's What You'll Bring to the Table:Minimum QualificationsBA/BS degree in a scientific/engineering discipline6+ years of experience in the Pharmaceutical industryKnowledge of current US and EU regulations and cGMPExperience with CTD format and content regulatory filingsExceptional written and oral communicationPreferred QualificationsBS or MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable8+ years of experience in regulatory in the pharmaceutical/biotech industry4+ years of experience in Regulatory CMC is desirableModerna 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-LG1-
Sr. Process Engineer I
ModernaTX, Inc., Norwood
The RoleIn this role, you will be responsible for ensuring operability and reliability of GMP manufacturing process equipment located at the Moderna manufacturing facility in Norwood, MA. This individual will work closely with Facilities, MS&T and equipment End Users to investigate and troubleshoot issues related to process equipment. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.Here's What You'll DoProvide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA. Serve as the System Owner focusing on the lifecycle management of the equipment from procurement to decommissioning, including the development and improvement of maintenance procedures, spare parts lists, and training for technicians and manufacturing operators.Drive results by owning and completing continuous improvement projects centering around reliability, safety, and process efficiency, or sub-projects of large capital projects, with high-quality technical documentation within the required quality systems and meeting project timelines to ensure the production schedule is not impacted.Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.Provide technical support and execution of EHS policies, procedures, and initiatives.Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early and late-stage manufacturing processes as well as continuously improve the facility fit process to support new product introduction and technology transfer projects.Engineer new and modify existing processes to ensure right first-time process start up.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.Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into assessing change controls, and continuous improvement initiatives.Mentor and train a group of engineers, who can be direct reports. Assess project requests for feasibility and scope, work with management teams to determine project priority, and track resource availability and project milestones in support of direct reports. Provide effective stakeholder feedback to all change controls, deviations, CAPAs and other quality documentation.Participate in internal and external audits, addressing any findings and implementing corrective actions.Support the process engineering on call team with troubleshooting guideline and investigations.Additional duties as may be assigned from time to time.Here's What You'll Need (Minimum Qualifications)Minimum Education Requirement: A bachelor's degree in chemical or mechanical engineeringMinimum of 8 years' relevant experience as a Process Engineer or similar roleHere's What You'll Bring to the Table (Preferred Qualifications)Minimum of 3 years' experience in a leadership roleExperience in a GMP environment.Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.)Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor. Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. 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 utilize strong decision-making skills to determine appropriate path forward for complex problems.Must be able to lead and manage large sized, complex projects.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.Demonstrated ability to manage own time and deliver to program timelines.Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.Proven ability to multitask.Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.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) -