Sr. Manager Cmo Operations

**The Role**:
This is a newly created role in the international fill and finish operations department to support Moderna’s Contract Manufacturing Organization (CMO) activities in Italy.

Reporting to the Associate Director, CMO Operation, International Fill and Finish Operation, the Sr. Manager will be part of Moderna’s energized International Fill and Finish team and will focus on Drug Product Operations and is responsible to support DP CMO operation internationally.

The role will develop strong process oversight and governance mechanisms for various work streams as we evolve into post COVID era, continue to advance Moderna’s pipeline products at DP CMOs. The Senior Manager will develop timelines and governance and lead cross functional project teams, support the CMO in project planning and execution, and coordinate the execution of tech transfer and manufacturing activities to meet submission timeline and fulfill market supply commitments. Mid to Long Term, the role will support and oversee production and supply harmonization between the different DP CMO’s.

**Here’s What You’ll Do**:
Represent Moderna in the interface with DP CMOs and ensure robust manufacturing operation.

Manage a visual metric/dashboard to provide an oversight of the production plan, CMO Efficiency and performance monitoring, OTIF and other operation KPIs.

Create and maintain detailed project plans to ensure clarity of deliverables and timing.

Track project tasks and ensure project timeline and deliverable adherence

Facilitate close collaboration, interactions and alignment between Moderna and CMOs.

As cross function project lead, ensure alignment and integration with internal line functions e.g. MS&T, Supply Chain, Logistics, Quality, Regulatory, etc.

Lead complex investigation and support GMP - CAPA implementation.

Lead continuous improvement initiatives / projects.

Manage complex Change Controls from an operational perspective.

**Here’s What You’ll Bring to the Table**:
**Education**: University degree in an appropriate discipline (e.g. sciences, engineering)

**Experience**: 8+ years in Pharmaceutical/Biotechnology GMP environment, incl CMOs.

Experience in commercial scale cGMP operation, deviation handling, GMP change control, and familiar with aseptic injectable products (vials, PFS).

**Plus**: Expertise in one or more of the following areas: Tech transfer, Aseptic processing / filling technology, cleaning validation, sterile filtration, visual inspection, labelling, packaging and cold chain management.

**Plus**: Understanding of SAP ERP system, serialization and aggregation requirements.

Ability to work in a fluid environment and foster a strong collaborative spirit

Ability to negotiate and sustain networking relationships.

Persuasive. Can do attitude with a balanced risk - quality mindset.

Strong analytical mindset, inquisitive and pragmatic.

Strong knowledge of project management tools/software, and digital solutions

Strong proficiency in English and Italian is an added advantage.

Strong communication, presentation and report writing 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.

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