Specialist, Analytical Technical Operations

Summary

The RoleThe Specialist, Analytical Technical Operations (ATO) supports analytical execution across CMC Development programs through testing coordination, stability study management, and digital operations support. This role partners with analytical scientists and cross-functional teams to translate inputs from laboratory and business systems into executable testing plans while helping ensure analytical activities align with program priorities and development timelines.Working across Analytical Development, Process Development, and other CMC functions, the Specialist contributes to operational excellence by supporting process improvements, digital workflows, and data management activities. The role combines scientific knowledge, project coordination, and analytical operations to support stability programs, improve laboratory efficiency, and deliver high-quality analytical data that enables product development decisions.Here's What You'll DoCoordinate and maintain analytical testing schedules by consolidating inputs from digital systems, program priorities, and laboratory capacity to support CMC Development activities.Support the authoring, execution, and maintenance of stability protocols and studies for novel mRNA and Lipid Nanoparticle (LNP) drug candidates in support of shelf-life determination, IND-enabling studies, and product development milestones.Compile, review, trend, and summarize analytical data; perform peer data review; prepare technical summaries and data packages; and communicate results to cross-functional stakeholders.Coordinate multiple program timelines simultaneously to help ensure testing milestones, study deliverables, and reporting commitments are completed on schedule.Partner with cross-functional teams to support forecasting activities, stage-appropriate testing strategies, sample management, and development program planning.Support the development and implementation of digital tools, automated workflows, and operational processes that improve laboratory efficiency and data quality.Assist with integrating laboratory and enterprise digital systems to improve planning, sample tracking, and analytical execution.Maintain accurate and compliant documentation while partnering with analytical scientists and technical teams to support successful execution of analytical activities.Identify opportunities for continuous improvement and participate in initiatives that enhance operational efficiency and data integrity.Here's What You'll Need (Basic Qualifications)Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline.3–6 years of experience in biotechnology, pharmaceuticals, analytical development, technical operations, or CMC Development.Experience supporting stability studies, analytical testing programs, or laboratory operations within a regulated environment.Experience working with LabVantage, Benchling, or similar Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), or laboratory data management systems.Strong organizational, analytical, and problem‑solving skills with the ability to manage multiple priorities in a fast‑paced environment.Effective written and verbal communication skills with the ability to communicate technical information across functional teams.This position is site‑based, requiring you to be at Moderna's site full‑time. This position is not eligible for remote work.Here's What You'll Bring to the Table (Preferred Qualifications)Experience supporting mRNA, LNP, biologics, or other advanced therapeutic modalities.Familiarity with CMC Development, stability programs, and regulatory expectations supporting product development.Experience supporting process improvements, workflow optimization, automation, or digital transformation initiatives.Ability to analyze and trend analytical data to support scientific and operational decision‑making.Experience coordinating cross‑functional projects or initiatives, including planning activities, stakeholder communication, and execution against established timelines.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well‑being resources are designed to support you—at work, at home, and everywhere in between.#J-18808-Ljbffr

Job Description

The RoleThe Specialist, Analytical Technical Operations (ATO) supports analytical execution across CMC Development programs through testing coordination, stability study management, and digital operations support. This role partners with analytical scientists and cross-functional teams to translate inputs from laboratory and business systems into executable testing plans while helping ensure analytical activities align with program priorities and development timelines.Working across Analytical Development, Process Development, and other CMC functions, the Specialist contributes to operational excellence by supporting process improvements, digital workflows, and data management activities. The role combines scientific knowledge, project coordination, and analytical operations to support stability programs, improve laboratory efficiency, and deliver high-quality analytical data that enables product development decisions.Here's What You'll DoCoordinate and maintain analytical testing schedules by consolidating inputs from digital systems, program priorities, and laboratory capacity to support CMC Development activities.Support the authoring, execution, and maintenance of stability protocols and studies for novel mRNA and Lipid Nanoparticle (LNP) drug candidates in support of shelf-life determination, IND-enabling studies, and product development milestones.Compile, review, trend, and summarize analytical data; perform peer data review; prepare technical summaries and data packages; and communicate results to cross-functional stakeholders.Coordinate multiple program timelines simultaneously to help ensure testing milestones, study deliverables, and reporting commitments are completed on schedule.Partner with cross-functional teams to support forecasting activities, stage-appropriate testing strategies, sample management, and development program planning.Support the development and implementation of digital tools, automated workflows, and operational processes that improve laboratory efficiency and data quality.Assist with integrating laboratory and enterprise digital systems to improve planning, sample tracking, and analytical execution.Maintain accurate and compliant documentation while partnering with analytical scientists and technical teams to support successful execution of analytical activities.Identify opportunities for continuous improvement and participate in initiatives that enhance operational efficiency and data integrity.Here's What You'll Need (Basic Qualifications)Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Chemical Engineering, or a related scientific discipline.3–6 years of experience in biotechnology, pharmaceuticals, analytical development, technical operations, or CMC Development.Experience supporting stability studies, analytical testing programs, or laboratory operations within a regulated environment.Experience working with LabVantage, Benchling, or similar Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), or laboratory data management systems.Strong organizational, analytical, and problem‑solving skills with the ability to manage multiple priorities in a fast‑paced environment.Effective written and verbal communication skills with the ability to communicate technical information across functional teams.This position is site‑based, requiring you to be at Moderna's site full‑time. This position is not eligible for remote work.Here's What You'll Bring to the Table (Preferred Qualifications)Experience supporting mRNA, LNP, biologics, or other advanced therapeutic modalities.Familiarity with CMC Development, stability programs, and regulatory expectations supporting product development.Experience supporting process improvements, workflow optimization, automation, or digital transformation initiatives.Ability to analyze and trend analytical data to support scientific and operational decision‑making.Experience coordinating cross‑functional projects or initiatives, including planning activities, stakeholder communication, and execution against established timelines.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well‑being resources are designed to support you—at work, at home, and everywhere in between.#J-18808-Ljbffr