Project Integrator Salary in Norwood, MA

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) -

The RoleIn this role, you will report to and work closely with the Director, Digital Quality to design, deploy and manage our expanding portfolio of digital quality management systems that support Quality and batch release processes. This role will help shape and deliver the long-term strategic vision for the Quality QMS Digital roadmap. This opportunity is unique in the pace and speed we expect and achieve.Who You Are:You are passionate about quality, continuous improvement, and enhancing systems to ensure optimal user experience and business efficiency. A master integrator gifted in bringing together people, concepts, and business goals with best-in-class execution. You thrive in a fast-paced environment and are comfortable rolling up your sleeves - if a process doesn't exist yet, you define it. You collaborate well amongst a team of expert peers.Here's What You'll DoDrive the execution of complex projects - proactively identifying risks / mitigation strategies while communicating to stakeholders and driving timelines through a blend of project management, technology, and business process expertise.Execute on our Digital Quality strategy with clear communication, prioritization, and escalation, both within Digital Quality and other cross functional teamsMentor a team of internal and external business analysts and software engineers designing, implementing, and maintaining our electronic quality management system, Veeva QualityPartner with digital stakeholders to ensure successful planning and integration of key systems into the quality management system while looking out for automation capabilities, and any artificial intelligence initiatives.Foster a culture of innovation within the team and with stakeholders to challenge the status quo leveraging both new technologies and creative solutions within existing systems.Support the Digital Quality Leadership Team by managing action plans and project plans to deliver short-, mid-, and long-term quality goals.Apply an operational excellence mindset to help Identify, devise, and recommend new opportunities to optimize current processes.Define and deliver a consistent systems governance methodology across applications with clear roles and responsibilities established throughout the system lifecycle: Implementation, Enhancement, and SupportEnsure GxP compliance is built into the design, delivery, and maintenance of all systems.Maintain inspection readiness through adherence to internal quality policies, procedures, and training.Participate in internal and external audits as digital quality expert for portfolio of processes.Hit the ground running immediately and work closely with various stakeholders in Quality to enable sustainable commercial operations.Here's What You'll Need (Minimum Qualifications)Bachelor's degree in science, technology, or another relevant academic discipline8-10 years of experience designing implementing and maintaining electronic quality management systems to support compliance processes in a regulated biotech or Pharma company.Experience with GAMP and GxP compliance regulationsHere's What You'll Bring to the Table (Preferred Qualifications)Strong understanding of batch release, quality management workflows, and related processesDemonstrated experience defining, scoping, and managing technology initiatives; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.Proficient in relevant project management software: Smartsheet, Excel, PowerPoint, Word, OneNote, MS Teams, etc. in addition to general knowledge with shared work environmentsPeople-orientedExtremely organized.Creative/innovative/problem solver that actively drives progress.Passion for people management and development in matrix teamsOutstanding communication, presentation, and writing skills and ability to tailor messaging to audience.Ability to manage multiple projects in a fast-paced environment.Ability to effectively collaborate in a dynamic, cross-functional matrix environment.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-KG1-

The Role:The Drug Substance Business Standards Lead is responsible for driving standardization of business processes and systems across the Global Drug Substance Network, with an emphasis on simple, robust solutions that fit the organization's broad mission. This role involves leading cross-site and occasionally cross-network teams for development and deployment of improved, standard processes across all applicable sites and teams. This role serves as a key strategic integrator for across the network, and will partner with functionally and geographically diverse groups to deliver results. Here's What You'll Do:Collaborate with the Global DS Lead Team and SMEs throughout the organization to identify improvement opportunities, prioritize, and align resources to drive standard development and implementation across the organization.Ensure any improvements are implemented across all DS Manufacturing Sites, driving towards a common set of operational standards and business practices over time.Set clear goals, objectives, and expectations for project/initiative team members and monitor execution. Establish governance approach to ensure progress and alignment over-time for the portfolio of standards being developed / implemented.Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.Follow all relevant GMP and GLP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.Here's What You'll Bring to the Table:Education: Bachelor's degree in STEM or relevant field. Master's degree preferred.Experience: Minimum of 12 years supporting manufacturing operations in a regulated environment. Working experience in a network setting and across diverse geographies is preferred.Specific Certifications or Training: Lean Six Sigma Green Belt or Black Belt certification preferred.Other Quantifiable Preference:Proven leadership experience, strong communication skills, and a track record of successful process improvement projects.Demonstrated strong understanding of GMP regulations and current industry practices.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) -