Sr. Data Scientist, CMC Data Science

3 weeks ago


Norwood, Massachusetts, United States Moderna, Inc. Full time

The Role

In this role, you will be part of a vibrant team responsible for providing data science and analytics support for GMP and Development Production operations at our Norwood site and global partners. You will contribute to process science data centric activities which support the Operations, Quality, Manufacturing Science and Technology, and Technical Development organizations including the advancement of commercial process monitoring and control tools, application of operational and predictive models, and development of statistical analysis and visualization data products.


Moderna is a global company utilizing both internal manufacturing and external commercial manufacturing organizations (CMOs). This requires integration and contextualization of data from diverse sources. Moderna utilizes a digital infrastructure for both GMP and non-GMP operations including MES electronic batch records, Delta V for process control, OSI PI as a process historian, SAP for materials control, and LIMS for analytical data, as well as internal applications and manual data sources.

Heres What Youll Do Represent the CMC data science organization by partnering with Commercial manufacturing operations to support and advance data driven business processes and activities Advance and streamline automated process monitoring and CPV methodology Provide expert opinion and analysis to support matters of product control strategy from a data and statistics perspective Lead the successful implementation of new process analytics tools through cross-functional collaboration focused on requirements, design, and maintenance Develop operational and investigational models to support manufacturing and development activities including multivariate and machine learning techniques Champion best practices organizationally in the data creation, pipelining, and utilization lifecycle Enable end to end data utilization and learning in the CMC organization by supporting key data initiatives and building relationships and integrations throughout the organization Provide SME knowledge for tool development and investigational support including advanced data manipulation, visualization, modeling, and interpretation Mentor junior team members and act as a key advisor to partners in the operations organization Additional duties as may be assigned from time to time Heres What Youll Need (Minimum Qualifications) MS/PhD in a quantitative or scientific discipline (e.g. engineering, mathematics, statistics, computer science) with BS MS) or 3-5+ (PhD) years of relevant data science/analytics experience in the pharmaceutical industry Highly proficient user of statistical programs to perform DOE analyses, multivariate analysis, and apply statistical process control techniques Demonstrable experience with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire, SIMCA) Prior experience working in a GMP environment and understanding of bioprocessing unit operations Heres What Youll Bring to the Table (Preferred Qualifications) Familiarity with building automated data pipelines and tools in a GMP setting Prior experience utilizing data to detect, diagnose, and solve issues in the manufacturing space Ability to apply strong verbal and written communication skills to effectively navigate a dynamic, cross-functional matrix environment Strong creative thinking and leadership skills 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 classesExclusive 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 Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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 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. Were 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 (EEO/AAP Employer)#LI-DS1

-



  • Norwood, Massachusetts, United States Moderna Full time

    Sr. Statistician, CMC Quantitative Sciences page is loaded Sr. Statistician, CMC Quantitative Sciences Apply locations Norwood, Massachusetts Technical Development time type Full time posted on Posted 4 Days Ago job requisition id R15859 The RoleIn this role, you will provide strategic statistical guidance and leadership to project teams. Working...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The RoleIn this role, you will be part of a vibrant team responsible for providing data science and analytics support for GMP and Development Production operations at our Norwood site and global partners. You will contribute to process data centric activities which support the Operations, Quality, Manufacturing Science and Technology, and Technical...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The RoleIn this role, you will be part of a vibrant team responsible for providing data science and analytics support for GMP and Development Production operations at our Norwood site and global partners. You will contribute to process data centric activities which support the Operations, Quality, Manufacturing Science and Technology, and Technical...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    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...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    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...


  • Norwood, Massachusetts, United States Moderna Theraputics Full time

    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...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The RoleIn this role, you will provide strategic statistical guidance and leadership to project teams. Working collaboratively with cross-functional teams, you will partner with colleagues in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research. Your understanding of these domains will be essential in identifying the...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The RoleIn this role, you will provide strategic statistical guidance and leadership to project teams. Working collaboratively with cross-functional teams, you will partner with colleagues in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research. Your understanding of these domains will be essential in identifying the...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The RoleModerna is seeking an accomplished Principal Statistician to join our Chemistry, Manufacturing, and Controls (CMC) Quantitative Sciences team onsite in Norwood, MA. As a pivotal member of the CMC Statistics team, you will provide strategic statistical guidance and leadership to project teams.Working collaboratively with cross-functional teams, you...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The RoleModerna is seeking an accomplished Principal Statistician to join our Chemistry, Manufacturing, and Controls (CMC) Quantitative Sciences team onsite in Norwood, MA. As a pivotal member of the CMC Statistics team, you will provide strategic statistical guidance and leadership to project teams.Working collaboratively with cross-functional teams, you...


  • Norwood, Massachusetts, United States BioSpace, Inc. Full time

    Job Details Position: Senior Manager, Global Regulatory CMC at Moderna The Role: The Senior Manager for Global Regulatory CMC will support regulatory CMC activities for one or more programs. They will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and communicate with Health Authorities...


  • Norwood, Massachusetts, United States Moderna Theraputics Full time

    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...


  • Norwood, Massachusetts, United States Moderna Theraputics Full time

    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...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The RoleThe CMC Program Management team in Technical Development seeks a Senior Manager to perform pivotal work focusing on the comprehensive management of CMC program integrated project plans. The candidate is expected to be a leading champion of cross-functional communication, aligning priorities for optimal project execution while demonstrating the...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for one or more programs. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with regulatory requirements...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for one or more programs. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with regulatory requirements...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Director, Global Regulatory-CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Director may manage a small group of individuals responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Director, Global Regulatory-CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Director may manage a small group of individuals responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collaborating with key stakeholders to execute the...


  • Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collaborating with key stakeholders to execute the...