Analyst, Quality Control - Microbiology & Bioassay

Moderna

Oxford, United Kingdom

As the Microbiology & Bioassay Quality Control Analyst at Moderna, you will embark on a transformative journey, reporting directly to the Associate Director of Quality Control. In this pivotal role, you'll perform critical Quality Control testing using cutting-edge Bioassay and Microbiology techniques within a GMP testing environment, supporting mRNA product production at Moderna’s manufacturing facility and affiliated organizations. Your work will encompass a broad range of microbiological and molecular biology methods, including but not limited to Bioburden, Sterility, BET, Micro sequencing, Agarose Gel Electrophoresis, UV/Vis measurement, Sanger Sequencing, protein concentration determination, qPCR, ELISA, and Cell-Based Potency testing. This role is instrumental in ensuring the highest quality of mRNA products, contributing to Moderna's mission of delivering the greatest possible impact to people through innovative mRNA medicines.

Here’s What You’ll Do:

Your key responsibilities will be:

Executing GMP QC Molecular Biology and Microbiology methods.
Supporting drug substances and drug products testing.
Conducting analysis related to Bioassay and Microbiology laboratory.
Participating in method transfers and qualification activities.
Assisting in the development, implementation, and maintenance of laboratory operational systems in accordance with cGMP requirements.

Your responsibilities will also include:

Providing support to audit teams.
Preparing and managing contract laboratory testing samples.
Performing general laboratory support activities.
Participating in equipment and method qualifications, validations, and method transfers.
Participating in authoring quality systems records and writing/revising SOPs, protocols, and reports.

The key Moderna Mindsets you’ll need to succeed in the role:

Pivot Fearlessly: This role requires adaptability and resilience, embracing change and new methodologies to ensure quality and efficiency in QC testing.
Pursue Options in Parallel: A strategic mindset to explore and implement various testing methodologies simultaneously, optimizing for the best outcomes in quality control processes.

Here’s What You’ll Bring to the Table:

BSc/BA in a relevant scientific discipline with 5-7 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.

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