QM237 Sr. Manager, Manufacturing Science and Technology (MS&T)

QM237 Sr. Manager, Manufacturing Science and Technology (MS&T)

26 mar

26 mar



Sr. Manager, Manufacturing Science and Technology (MS&T;)


Madrid, Spain

The Role:

This is a newly created role in the Manufacturing Science and Technology (MST) department to support Moderna’s Contract Manufacturing Organization (CMO) activities in Europe.

Reporting to the Director of MS&T;, the Snr Manager, MS&T; will be part of Moderna’s Manufacturing Science and Technology team responsible for technical support of Moderna cGMP manufacturing activities at ROVI, Madrid.

The individual will work closely within MS&T;, Regulatory, Quality and Process Development, to ensure all aspects of process validation are successfully executed and continuously maintained. The individual will support tech transfer,

process validation activities and life cycle CMC activities, including protocol generation, oversight of CMO execution and summary report generation. The Snr MS&T; manager will also be responsible for ensuring continued process verification for Moderna products.

Here’s What You’ll Do:

- Ensure successful technology transfer of Moderna processes into CMOs operations.

- Manage and document process and project information with a robust documentation package.

- Ensure successful validation of Moderna manufacturing processes at CMOs. Review and approve validation protocols and summary reports.

- Manage and regularly review manufacturing data from CMO activities. Identify and investigate trends. Be the point of contact for manufacturing issues requiring technical investigations. Identify root cause. Coordinate and resolve issues with effective CAPAs

- Manage change as part of a Global Change Control forum

- Maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions.

- Lead and manage CPV in close collaboration with CMOs. Consolidate CPV data across all global sites include drug substance and drug product CMOs.

- Analyze manufacturing performance through data review and analyses. Generate periodic reports to support internal QMR and regulatory filings.

- Represent MS&T; in audits.

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

- M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.)

- A minimum of 10 years related work experience

- Direct experience providing technical support of cGMP manufacturing operations in biologics manufacturing or parenteral drug product manufacturing. Experience to include technology transfer, investigations, and change management.

- Experience in working with CMOs; and supporting commercial cGMP manufacturing processes.

- Experience using statistical process control and process analytics for monitoring and improving control of processes.

- Demonstrated capability of working cross functionally in a technical area outside of core expertise.

- Outstanding communication skills (verbal and written).

- Ability to manage projects in a fast-paced environment.

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

- Ability to adapt to new and challenging technical opportunities.

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Don't forget to mention EuroPharmaJobs when applying.

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