Scientist Research Associate
hace 2 semanas
**The Role**:
Moderna is seeking a Senior Research Associate (SRA) with expertise in technical writing for a position-based Madrid. The individual in this role will be responsible for writing standard operating procedures, manages documentation compliance and change control. Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs and SOPs. Must perform all work independently with mínimal supervision.
**Here’s What You’ll Do**:
Monitor updates to compendial chapters and updating QC SOPs accordingly
Drafting new SOPs, qualification and validation protocols and reports.
Authoring Change controls for updates to validated methods and updating the methods accordingly
Periodic reviews of current Test Methods and SOPs
CMC Filing support
**Here’s What You’ll Bring to the Table**:
**Minimum education required**: Bachelor’s degree in a relevant scientific discipline ( Chemistry, Biochemistry, Molecular Biology, or related science)
**Minimum education**: BS/MS (Chemistry, Biochemistry, Molecular Biology, or related science) with 2-5 years of industry experience, or MS with at least 2 years of industry experience (Chemistry, Biochemistry, Molecular Biology, or related science), writing and/or performing analytical, molecular, biochemical, biophysical and/or cellular assays.
Minimum previous technical writing experience
Experience with Veeva or similar quality documentation system.
Experience with ELISA and PCR/qPCR assays
Experience with HPLC (SEC, RP, HIC) and cIEF
Experience with LIMS or other data entry software
Ability to work independently and effectively in a highly dynamic environment
Creative/innovative/problem solver
Excellent communication, presentation, and writing skills
Fluently (written / spoken) in English.
**Preferred**: Experience with nanoparticle formulations
**Preferred**: Familiarity with nucleic acid and protein chemistry, and analytical characterization of biomolecules
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 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 winter break
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.
About Moderna
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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