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Analyst, Quality Control
hace 3 meses
.The Role:Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.Moderna is solidifying its footprint within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.The Microbiology & Bioassay Quality Control Analyst, reporting to the Associate Director of Quality Control, will perform Quality Control testing using various Bioassay and Microbiology techniques in a GMP testing environment for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations. This role primarily focuses on Bioassay, with future expansion to support microbiology anticipated. The QC Analyst will also contribute to related method transfers and qualification activities and may perform assigned projects.Your key responsibilities will be:Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, and supporting ELISA, Cell-Based Potency testing, and other methodologies as needed.Execute GMP QC Microbiology methods, including Sterility testing, Bioburden Analysis, Endotoxin, Micro sequencing, and other general methods such as TOC and Conductivity testing.Support testing for drug substances and drug products, generating testing data to support other studies as needed.Conduct analysis related to Bioassay and Microbiology laboratory, including TOC, Conductivity, Bioburden, Sterility, Endotoxin, Sanger Sequencing, qPCR, ELISA, Cell-Based Potency testing, and more.Perform routine environmental monitoring and critical utility sampling activities, if required.Your responsibilities will also include:Collaborate with AS&T groups on new methods transfers and participate in method transfer projects for internal and external testing labs.Assist in developing, implementing, and maintaining general laboratory operational systems in accordance with cGMP requirements.Provide support to audit teams for internal and vendor audits.Prepare and ship/receive contract laboratory testing samples, including those intended for microbiological identification
