Sr. Manager, Manufacturing Operations Ds

**The Role**:
This role is an exciting opportunity to be part of a growing CMC organization, responsible for the manufacturing and supply of Moderna’s COVID mRNA vaccine internationally, as well as preparation for commercial expansion and manufacturing for further products coming via our pipeline.

**Here's What You’ll Do**:
Lead supporting efforts at CMOs in executing operational and tactical plans. Partner with Quality, Technical Development, Manufacturing Science and Technology, Supply Chain, Legal and Regulatory colleagues on all aspects of the relationships with the CMOs.

Ensure, in collaboration with quality and MS&T, that the appropriate qualification, maintenance, trainings, and validations are performed to meet the appropriate Moderna’s requirements.

In collaboration with Quality and MS&T, coordinate investigations and troubleshooting efforts at CMOs

Lead and track change controls and life cycle projects at CMOs impacting manufacturing operations, in close collaboration with cross-functional team. Act as a Site Change coordinator.

Lead and support Moderna manufacturing projects, including process changes and new products.

Track project tasks and efforts associated with the expansion of the international manufacturing organization. Ensure full alignment and integration with multiple functions.

Establish, manage, and lead cross-functional project teams.

Collaborate with internal/external cross-functional teams to track production plan, batch release, shipping, and disposition activities at CMOs and Moderna, as applicable.

Coordinate reviews and approvals of various documentations from CMOs (e.g. MBRs, deviations)

Write/revise and approve the appropriate GMP documentations. e.g: change request, deviations, master batch records, annual product quality reviews (APR/PQR), internal SOP´s.

Support contract management process with CMO. Partner with key Procurement, Legal and Finance in the preparation of Change Orders (CO) and supportive agreements. Ensure contract terms are executed including issuance of purchase orders, forecasts and other deliveries.

Person in plan at CMO to build strong interdependent relationship and ensure proper operational oversight, timely resolution, and action-oriented improvement plans.

**Here’s What You’ll Bring to the Table**:
**Education**: University d degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)

**Experience**: 8+ years in Pharmaceutical/Biotechnology Industry

Knowledge and expertise on project management preferred but not required.

Experience with 5S and Lean Manufacturing, Lean Six Sigma Green belt or black belt preferred but not required.

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

Ability to negotiate and sustain networking relationships

Solid judgement with ability to make good decisions

Strong proficiency in English. German is an advantage.

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.