(Fixed Term) Analyst, Quality Control, Microbiology
Description
The role of (Fixed Term) Analyst, Quality Control, Microbiology at Moderna's Harwell facility involves supporting GMP manufacturing operations. Key responsibilities include conducting routine environmental and critical utility monitoring, performing microbiological testing on raw materials, excipients, and drug substances for mRNA products, and collaborating on method transfers and validations. This position requires operating at the intersection of digital systems and biotechnological innovation to advance mRNA technology and contribute to global health initiatives.
What We're Looking For
Conduct routine environmental monitoring (EM) and sampling of critical utilities in a GMP manufacturing facility.
Execute microbiological analyses including TOC, Conductivity, Bioburden, Endotoxin, Sterility, and other GMP QC methods.
Support GMP testing for product release, stability, and validation samples.
Prepare, ship, and receive contract laboratory samples, including those for microbiological identification.
Participate in new microbiological method transfers in collaboration with Analytical Sciences & Technology (AS&T) teams.
Support development, implementation, and maintenance of laboratory systems in line with cGMP expectations.
Perform general laboratory support activities including reagent preparation, equipment maintenance, and housekeeping.
Participate in audit readiness activities.
Assist in equipment and method qualifications, and potentially troubleshoot assay methods and instrumentation.
Draft and revise SOPs, protocols, reports, and contribute to quality system documentation (e.g., deviations, CAPAs, EM excursions, and change controls).
Apply Good Documentation Practices and ensure full compliance with GxP and Data Integrity requirements.
Complete all assigned training per schedule and requalification timelines.
Support junior team members as required with data review, troubleshooting, and training.
Ideal Candidate
BSc in a relevant scientific discipline.
5 years Quality Control experience in a cGMP organization with a focus on Microbiology.
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.
Minimum Education
Bachelor's Degree
Hard Skills
Soft Skills
Benefits
Special Commitments
Fixed-Term,Must be willing to work on-site full-time,Not eligible for remote work
About the Company
Moderna, Inc.
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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