Senior Specialist, Quality Control, Microbiology

Moderna

Harwell, United Kingdom

In this pivotal role, you will perform critical Quality Control testing using cutting-edge Bioassay and Microbiology techniques within the 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:

Utilize QC Microbiology knowledge and investigational skills to set-up and implement the new QC laboratories, identify and resolve testing issues, and drive continuous improvement in laboratory operations;
Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements;
Support facility, equipment qualification, validation, and maintenance activities;
Support method transfers and qualification activities;
Prepare and manage contract laboratory testing samples;
Perform on-the-job (OJT) training and act as a mentor to QC Microbiology staff;
Conduct analysis related to Bioassay and Microbiology laboratory;
Ensure day-to-day operations are successful;
Assist with scheduling and resource allocation;
Represent the QC Microbiology team in the absence of management.

Your responsibilities will also include:

Work directly with management to ensure QC goals and milestones are met;
Lead and organize continuous improvement projects;
Troubleshoot issues related to equipment, laboratory procedures, and assay performance;
Write/revise SOPs, technical protocols, and reports;
Assist with audit preparation and regulatory compliance;
Responsible for alarms in the QC Microbiology Lab;
Stay updated with the latest advancements and trends in the field of microbiology and recommend and implement new technologies and methodologies as appropriate.

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

We pursue options in parallel: You will be involved in setting up new QC laboratories and managing multiple tasks simultaneously, requiring a strategic approach to select the best solutions;
We question convention: Implementing and validating new methods and technologies will demand innovative thinking and challenging established protocols.

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

BS in a relevant scientific discipline;
7+ years relevant experience or 5+ years experience with a Masters in a relevant scientific discipline;
Quality Control experience in a cGMP organization with a focus on Microbiology;
In-depth knowledge of microbiological principles, techniques, and methodologies;
Attention to detail and high level of accuracy in performing microbiological tests and analysis and reviewing and approving test data;
Proficient in using microbiological testing equipment and software;
Good understanding of regulatory requirements and industry standards related to microbiology;
Ability to collaborate effectively in a dynamic, cross-functional matrix environment and an ability to adapt to changing priorities and deadlines;
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment;
Proven ability to conduct investigations;
Strong organizational and time management skills to prioritise tasks and meet project timelines;
Continuous learning mindset to stay updated with advancements in the field of microbiology;
This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.