.The Role : Moderna is seeking a Scientist, AS&T, based at their Madrid laboratory.
This role will work with key stakeholders and within a matrixed team to execute on CMC deliverables pertaining to commercial analytical methods.
This role entails a broad scope of analytical activities, including method validations and transfers, change management projects for analytical methods, and authoring regulatory submissions for methods.
This is a primarily non-laboratory scientific position in AS&T, but with potential for some lab-based work as needed.Here's What You'll Do :Lead method validation strategy for commercial programs.Lead analytical method validation, transfer, optimization, and remediation projects.Author method validation protocols, reports, and master validation plans.Provide expert knowledge for GMP investigations relating to commercial Analytical Chemistry, Raw Materials, and Bioassay methods.Author regulatory submissions and support regulatory inspections.Participate in cross-functional, multi-site, global meetings/projects and provide commercial method lifecycle monitoring and maintenance oversight.Other responsibilities as needed.Here's What You'll Bring to the Table :Minimum education required : Bachelor's degree in a relevant scientific disciplineMinimum experience required : BS: 10+ years, MS: 6+ years in a GMP laboratory setting focused on analytical chemistry, bioassay, raw materials, etc.Ability to navigate through ambiguity and rapid growth and adapt to change.Understanding and experience with ICH, USP, Ph.
Eur., FDA guidelines.Knowledge and expertise in analytical method validations and method transfers in GMP environments.Experience in assessing, writing, and evaluating laboratory investigations pertaining to analytical methods.Ability to lead and manage projects of significant scope and complexity, while meeting all deliverables and timelines.Ability to think critically and demonstrate troubleshooting and problem-solving skills.Ability to interact effectively with all levels of personnel within the organization and externally with CTOs, CMOs, and third parties.Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well-beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdownEducational resourcesSavings and investmentsLocation-specific perks and extras!The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work