Sr. Specialist Cmo Operations

**The Role**:
Reporting to the Associate Director or Sr. Manager - CMO Operations, the Senior Specialist is a newly created position to support buildup of the External Manufacturing Fill Finish function in Italy for Moderna.

The Senior Specialist will liaise with Moderna’s International Fill Finish Contract Manufacturing Organizations (CMOs) to ensure on-time and in-full deliveries. This includes supporting the Director, International Fill Finish Operations to ensure all operational related activities at the Fill Finish CMOs are conducted to meet all of Moderna’s requirements. This role will collaborate with cross functional to execute on Moderna’s production strategy.

**Here’s What You’ll Do**:
Support the Director, CMO Operations in various tasks related to the buildup of GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs).

Act as a counterpart for FF CMOs team members to ensure on-time and in-full deliveries.

Partner with Quality, Technical Development, Manufacturing Science and Technology, and Regulatory colleagues to resolve production issues, perform investigation and manage change actions.

Ensure operational related activities at the FF CMOs are conducted to meet Moderna’s requirements

Ensure that Moderna’s process requirement are strictly implemented by the CMOs

Support and perform the reviews of production performance, KPIs, CPV at CMOs

Drive / lead continuous improvements at FF CMOs.

In collaboration with Quality coordinate investigations and troubleshooting efforts at FF CMOs

Write / revise / coordinate the review GMP documentations to support production activities.

Frequently visit and maintain presence at the external partners’ sites and build strong interdependent relationship with the CMO Counterparts in order to assess the as is state & risks for action-oriented improvement plans.

Performs other administrative duties as required.

**Here’s What You’ll Bring to the Table**:
Bachelor's Degree with 5-8 years of experience in biopharmaceutical operations or a Master’s Degree with 2-5 years industry experience; Degree in Engineering or Life Sciences is preferred.

Positive, pragmatic, can-do attitude.

Driven, result oriented mindset.

Strong analytical mind with good project management skills.

Good report writing, presentation and communication skills.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a 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 seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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.

LI-TR1
- #LI-Remote