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Posted : Friday, August 16, 2024 06:18 PM
The Role:
Moderna is seeking an Executive Director, CMC Quantitative Sciences to build and lead a centralized data analytics and statistical sciences function that supports all of CMC (Technical Development, Manufacturing, Quality, CMC Regulatory, et al.
).
The role involves leading a dedicated team of statisticians, data scientists and engineers, with overall accountability for defining and delivering a robust data analytics, process modeling, and statistical sciences capability in support of Moderna’s mRNA portfolio.
As the lead for this core capability, this person will partner across CMC and with Digital to guide the scientific data strategy, architecture, and governance, and enable efficient development and manufacturing process analysis and decision-making tools.
Overall, the focus is on facilitating efficient sharing, consumption, and interpretation of data to both define optimal control strategies and drive continuous improvement throughout the CMC product lifecycle.
The team functionally reports into the Technical Development organization and will operationally report into the various manufacturing business units within CMC, supporting process monitoring and manufacturing data needs, all the while building new data science, statistics, and modeling capabilities for the future.
The Technical Development organization within CMC is comprised of scientists, engineers, and problem solvers that develop and implement the most innovative, advanced, and robust platform processes and analytical technologies to deliver Moderna’s medicines.
The role is based in Moderna’s Moderna Technology Center campus in Norwood, MA, but may require presence at the Cambridge site as well as occasional travel to manufacturing and analytical testing sites within the network as needed.
Here’s What You’ll Do: Provide team leadership in developing and delivering the end-to-end data analytics and statistical science core capability that supports Moderna’s CMC development lifecyle, from process development through GMP commercial manufacturing and regulatory approval.
Partner with all CMC functions to assess needs, identify opportunities, and implement tools and approaches that enable access and use of data, including machine learning, multivariate modeling, process trending, process monitoring, design of experiments, etc.
Provide team leadership and organizational direction toward best practices that enable efficient sharing, consumption, and interpretation of data throughout the CMC product lifecycle Advise and influence organization-wide data governance strategies, including architecture of software platforms, data standards, knowledge management, and data-related business processes applicable across the CMC organization Build and mentor a dedicated, high-performing team of internal subject matter experts across a broad spectrum of data analytics, mathematical sciences, and CMC statistics disciplines, consolidating expertise for data-driven decision making and the development of fundamental data analytics workflows and process models.
Establish and evolve standards and practices for the management of analytics pipelines, modeling, analysis, visualization, and presentation of data Maintain routine process and platform monitoring tools and methodologies supporting clinical and commercial manufacturing Here’s What You’ll Bring to the Table: PhD degree in Chemical/Biochemical Engineering, Statistics, Mathematics or a related discipline with technical experience relevant to areas within the quantitative sciences disciplines.
Prior experience with quantitative sciences disciplines and technologies that support cGMP, process development/ scale-up and methods /process validation, continuous process verification, and preparation of regulatory submissions, is preferred, with 15+ years of industry experience in pharmaceutical development and/or manufacturing sciences and technology.
Prior experience in a fast-paced environment with demonstrated ability to leverage external collaborations with industry and academic partners Demonstrated understanding of the development lifecycle from R&D through commercialization, including an understanding of the interdependencies of functional groups.
Strong technical/scientific experience in product development and commercialization Experience in late-stage development and project management, including strong communication skills and ability to operate effectively in ambiguity by anticipating and balancing needs of multiple stakeholders Demonstrated experience developing and implementing an innovative data and analytics solutions Skilled at facilitating teams and building consensus across diverse levels and areas of the company.
Current knowledge of US, EU, Japan and ICH regulatory requirements among others.
Strong written and oral communication skills 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 options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • D iscretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! About Moderna Since 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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.
com .
(EEO/AAP Employer) -
).
The role involves leading a dedicated team of statisticians, data scientists and engineers, with overall accountability for defining and delivering a robust data analytics, process modeling, and statistical sciences capability in support of Moderna’s mRNA portfolio.
As the lead for this core capability, this person will partner across CMC and with Digital to guide the scientific data strategy, architecture, and governance, and enable efficient development and manufacturing process analysis and decision-making tools.
Overall, the focus is on facilitating efficient sharing, consumption, and interpretation of data to both define optimal control strategies and drive continuous improvement throughout the CMC product lifecycle.
The team functionally reports into the Technical Development organization and will operationally report into the various manufacturing business units within CMC, supporting process monitoring and manufacturing data needs, all the while building new data science, statistics, and modeling capabilities for the future.
The Technical Development organization within CMC is comprised of scientists, engineers, and problem solvers that develop and implement the most innovative, advanced, and robust platform processes and analytical technologies to deliver Moderna’s medicines.
The role is based in Moderna’s Moderna Technology Center campus in Norwood, MA, but may require presence at the Cambridge site as well as occasional travel to manufacturing and analytical testing sites within the network as needed.
Here’s What You’ll Do: Provide team leadership in developing and delivering the end-to-end data analytics and statistical science core capability that supports Moderna’s CMC development lifecyle, from process development through GMP commercial manufacturing and regulatory approval.
Partner with all CMC functions to assess needs, identify opportunities, and implement tools and approaches that enable access and use of data, including machine learning, multivariate modeling, process trending, process monitoring, design of experiments, etc.
Provide team leadership and organizational direction toward best practices that enable efficient sharing, consumption, and interpretation of data throughout the CMC product lifecycle Advise and influence organization-wide data governance strategies, including architecture of software platforms, data standards, knowledge management, and data-related business processes applicable across the CMC organization Build and mentor a dedicated, high-performing team of internal subject matter experts across a broad spectrum of data analytics, mathematical sciences, and CMC statistics disciplines, consolidating expertise for data-driven decision making and the development of fundamental data analytics workflows and process models.
Establish and evolve standards and practices for the management of analytics pipelines, modeling, analysis, visualization, and presentation of data Maintain routine process and platform monitoring tools and methodologies supporting clinical and commercial manufacturing Here’s What You’ll Bring to the Table: PhD degree in Chemical/Biochemical Engineering, Statistics, Mathematics or a related discipline with technical experience relevant to areas within the quantitative sciences disciplines.
Prior experience with quantitative sciences disciplines and technologies that support cGMP, process development/ scale-up and methods /process validation, continuous process verification, and preparation of regulatory submissions, is preferred, with 15+ years of industry experience in pharmaceutical development and/or manufacturing sciences and technology.
Prior experience in a fast-paced environment with demonstrated ability to leverage external collaborations with industry and academic partners Demonstrated understanding of the development lifecycle from R&D through commercialization, including an understanding of the interdependencies of functional groups.
Strong technical/scientific experience in product development and commercialization Experience in late-stage development and project management, including strong communication skills and ability to operate effectively in ambiguity by anticipating and balancing needs of multiple stakeholders Demonstrated experience developing and implementing an innovative data and analytics solutions Skilled at facilitating teams and building consensus across diverse levels and areas of the company.
Current knowledge of US, EU, Japan and ICH regulatory requirements among others.
Strong written and oral communication skills 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 options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • D iscretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! About Moderna Since 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.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.
com .
(EEO/AAP Employer) -
• Phone : NA
• Location : Norwood, MA
• Post ID: 9003757989
