In this role, the Senior Manager, International Manufacturing Operations will be part of a team responsible for Moderna’s manufacturing activities at 3rd-party contract manufacturing organizations (CMO). This role includes responsibility for standardizing communication, data, processes, and reporting across the department and internal stakeholders. This includes responsibility to ensure all operational related activities at the CMOs are tracked and reported to meet Moderna requirements.
The role will develop strong oversight, processes and governance mechanisms to ensure full integration and alignment with each one of the individual functions involved in the Moderna and CMOs relationship: Manufacturing, Quality Assurance, Supply Chain, Regulatory, Legal and Finance.
Responsible for creating and maintaining tracking and reporting tools for the external international manufacturing department.
Build and define program management infrastructure for External Manufacturing Organization.
Act as a Project Manager for Modern International manufacturing related projects. Establish, manage and lead cross-functional project team
Collaborate with internal cross-functional team to track and report on change controls and deviation investigations to support process and other operational changes at the CMOs
Collaborate with internal cross-functional team to track and report production plan, batch release, shipping, and disposition activities at CMOs as applicable
Coordinate and perform the reviews for process performance and Key Performance Indicators (KPIs).
Coordinate the review and approval of various documents from CMOs (e.g. MBRs, deviations, change controls, internal SOP´s)
Create and maintain detailed project plans to ensure clarity of deliverables and timing.
Track and report continuous improvement initiatives across the department.
Support the preparation and coordination of Business Reviews meetings and Stco and with CMOs as well as within Moderna Organization.
Coordinate CMO/supplier team, including scheduling and facilitating meetings, sending out agendas, writing and distributing minutes, managing team documentation, and tracking goals and action items.
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: Advanced degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
Experience: 5+ years in Pharmaceutical/Biotechnology Industry.
Strong knowledge and expertise with project management reporting and tracking tools, as well as digital solutions.
Experience with 5S and Lean Manufacturing, Lean Six Sigma Green belt or black belt preferred.
Outstanding communication skills (verbal and written) to collaborate with senior CMC Management in a dynamic, cross-functional matrix environment.
You drive for results – you set a high bar for yourself and others
Adapts departmental plans and priorities to address resource and operational challenges
A curious mindset that allows you to constantly learn and challenge the status quo
Good critical thinker that can anticipate the needed next step and therefore can work independently
A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement.
Ability to navigate through ambiguity and rapid growth and adapt to change.
Strong proficiency in English. German is an advantage.
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’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
Moderna is a smoke-free, alcohol-free and drug-free work environment.