Analyst, Quality Control

**The Role**:
Reporting to the Associate Director of Quality Control, the Microbiology & Bioassay Quality Control Analyst, will perform Quality Control testing using Bioassay and Microbiology various testing techniques in a GMP testing environment for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations:
Microbiological method, including Bioburden, Sterility, BET, Micro sequencing, others.

Molecular Biology methods, focusing on molecular and protein analytics such as: Agarose Gel Electrophoresis, UV/Vis measurement, Sanger Sequencing, protein concentration determination and qPCR, ELISA, Cell-Based Potency testing, and other methodologies as needed.

routine testing for cGMP QC raw materials, excipients, drug substance and finished product,

This position will contribute to related method transfers and qualification activities; The QC Analyst may also perform projects as assigned.

**Here’s What You’ll Do**:
Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, but also supporting ELISA, Cell-Based Potency testing, and other methodologies as needed.

Execute GMP QC Microbiology methods, focusing on Sterility testing, Bioburden Analysis, Endotoxin, Micro sequencing in addition to other general methods such as TOC and Conductivity testing and other methodologies as needed.

Support testing for drug substances and drug products, including generation of testing data to support other studies as needed.

Conduct analysis related to Bioassay and Microbiology laboratory such as: TOC, Conductivity, Bioburden, Sterility, and Endotoxin, Identification by Sanger Sequencing, qPCR methods execution, ELISA, Cell-Based Potency testing and others.

Perform routine environmental monitoring and critical utility sampling activities, if required

Collaborate with AS&T groups on new methods transfers. Participated in method transfer projects for internal and external testing labs.

Assist in development, implementation, and maintenance of 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.

Perform general laboratory support activities including reagent preparation, equipment maintenance and housekeeping.

May participate in equipment and method qualifications, validations, and method transfers.

Perform data entry utilizing good documentation practices.

May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting.

Participate in authoring quality systems records such as investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports.

**Here’s What You’ll Bring to the Table**:
BSc/BA in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus in Molecular Biology, DNA Sequencing and Microbiology.

Hands on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, and Sanger Sequencing.

Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others)

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.

Working experience in a GMP environment.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

Proven ability to conduct investigations.

**Le rôle**:
Rendant compte au directeur associé du contrôle de la qualité, l'analyste du contrôle de la qualité en microbiologie et bioanalyse effectuera des tests de contrôle de la qualité en utilisant des techniques de bioanalyse et de microbiologie dans un environnement de test BPF pour les produits à ARNm produits dans l'installation de fabrication de Moderna et les organisations contractuelles affiliées:
Méthodes microbiologiques, y compris la charge microbienne, la stérilité, le test de l'endotoxine bactérienne (BET), le séquençage microbien, et autres.

Méthodes de biologie moléculaire, axées sur l'analyse moléculaire et protéique telles que l'électrophorèse sur gel d'agarose, la mesure UV/Vis, le séquençage de Sanger, la détermination de la concentration protéique, la qPCR, les tests ELISA, les tests de puissance basés sur les cellules, et autres méthodologies selon les besoins.

Tests de routine pour les matières premières, les excipients, la substance médicamenteuse et le produit fini conformes aux BPF. Ce poste contribuera aux transferts de méthodes connexes et aux activités de qualification. L'analyste du contrôle de la qualité peut également effectuer des projets qui lui sont assignés.

**Voici