Sr. Manager, Bioanalytical and Molecular Assays, UK Lab Operations

Moderna

Oxford, United Kingdom

The Role

We are seeking a Senior Lab Operations Manager for our new Clinical Assay Laboratory within the Bioanalytical and Molecular Assay team. The ideal candidate will have extensive experience managing laboratories in a GLP/GCLP regulated environment, with a strong background in handling clinical samples and laboratory information management systems. This role requires someone who thrives in a fast-paced, scientifically stimulating environment, and who is capable of independent work while fostering a collaborative team culture. Training and mentorship will be provided to ensure the right candidate excels in this position.

Here's What You’ll Do:

Your key responsibilities will be:

Develop bioanalytical operations activities, timelines, metrics, and quality standards across clinical studies.
Act as Subject Matter Expert and System Owner for various pieces of equipment.
Use your experience to complement our existing processes, and balance continual improvement with ensuring quality and compliance are maintained.
Manage biospecimen accessioning for clinical studies (phase I-III) and monitor biospecimens, ensuring compliance with the Human Tissue Act and Good Clinical Practice.
Use various LIMS such as Thermo Fisher’s Watson and LabVantage, and develop our procedures and usage to increase efficiency and compliance.
Help manage the lab inventory and equipment with vendors and on-site contractors, ensuring they are accurate and compliant with SOPs.
Write laboratory SOPs that follow Moderna’s policies and regulatory requirements for both the US and UK.
In collaboration with Moderna’s Critical Reagents team, maintain a robust system for monitoring, tracking, and storing critical reagents to ensure their availability and quality.

Your responsibilities will also include:

Participate in the strategic implementation of new technology to promote lab automation.
Lead ordering supplies (chemicals, reagents, personal protective equipment, etc.) as necessary.
Perform laboratory audits to check for compliance and safety issues.
Schedule laboratory equipment maintenance to align with laboratory requirements.
Maintain compliance with regulations and SOPs as per current regulatory standards.
Provide expertise on best practices for operations and compliance.
Schedule laboratory and equipment time for staff.
Participate in the laboratory workflow daily, including quality control on instruments, and schedule maintenance with vendors as needed.
Ensure that all team members are trained to use laboratory equipment, software, and supplies safely and efficiently.
Contribute to the lab safety plan, CoSHH, and Risk Assessments as necessary.
Schedule safety training for new hires or team members entering new roles.
Enforce policies around personal protective equipment.
Oversee the cleansing and sanitizing of the lab according to EHS policies and Laboratory SOPs.
Work closely with colleagues in the clinical development organization as well as other cross-functional groups.
Mentor and train junior members of the group.

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

Prioritize the platform: Focus on maintaining and improving our laboratory operations to support the overall success of our mRNA platform.
Pursue options in parallel: Manage multiple projects simultaneously, ensuring all tasks are completed to the highest standards.

Here's What You'll Bring to the Table

BSc/MSc in a related scientific discipline is essential
9+ years laboratory management experience in a GCP/GLP or similar regulated laboratory (regulated bioanalysis preferred)
Willingness to learn new concepts and challenge boundaries; adaptability to change; confidence and ability to lead.
Organization and attention to detail; ability to handle multiple projects in a fast-paced environment.
Strong interpersonal skills with an eagerness to work with and support colleagues in other departments.
Proven ability to develop and work independently and to collaborate cross-functionally to accomplish goals in a timely manner.

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