Scientist, Analytical Science
hace 2 semanas
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 discipline
Minimum 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 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.
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.
Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.
Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna is a smoke-free, alcohol-free and drug-free work environment.-
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