Manager, Manufacturing

Vor 6 Tagen

Visp, Schweiz Moderna Vollzeit

**The Role**:
**Here’s What You’ll Do**:

- Work cross-functionally to assist in the planning and execution of GMP related CMO activities, batch record, deviation management, change controls as well as several project initiatives.
- Closely partner with QA and MS&T peers for closure of documentation required for timely release.
- Initiate and drive to completion deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
- Provide operational support and guidance as needed to contract manufacturing operations (e.g.: attend meetings, person in plant review and approval of CMO documentation.)
- Write /revise and approve the appropriate GMP documentations. e.g.: change request, deviations, master batch records.
- Coordinate and support investigations and troubleshooting efforts at CMOs, in collaboration with Quality and MS&T.
- Monitors and trends batch record errors and deviations provides management with quality indicator data, and collaborates with stakeholders to reduce sources of error.
- Track and asses effectiveness of CAPAs as well as different improvement activities.
- Lead small cross-functional teams to drive manufacturing operations changes and improvements
- Attend daily operational meetings at the CMO.

**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.)
- At least 10 years’ experience within similar role
- Previous work experience in cGMP environment and with deviation or investigation management systems.
- Outstanding communication skills in English (verbal and written, basic knowledge of German is favorable).
- 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.

**About Moderna**
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
- Moderna is a smoke-free, alcohol-free and drug-free work environment._

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