Senior Manager, International Manufacturing Operations

Job content

The Role

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). The Manager will be one of the primary points of contact for Moderna internal stakeholders for the department including Contract Manufacturing Organizations (CMO) information. This includes responsibility to ensure all operational related activities at the CMOs are tracked and reported to meet Moderna requirements.

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 control and life cycle projects at CMOs impacting manufacturing operations, in close collaboration with cross-functional team.
• Lead and track production plan, batch release, shipping, and disposition activities at CMOs as applicable.
• Represent mRNA-1273 and other projects for accelerated scale up of international manufacturing
• 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.
• Coordinate reviews and approvals of various documentations from CMOs (, 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
• Lead periodic review and execution of the MPS (Master Production Schedule) in close collaboration with Supply Chain.
• CMO KPI and efficiency monitoring. Drive for and implement agreed continuous improvements.
• Support the preparation and coordination of Business Reviews meetings with CMOs as well as within Moderna Organization.
• BOM management within Manufacturing organization.
• 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) preferred

• Experience: 10+ years in Pharmaceutical/Biotechnology Industry
• Knowledge and expertise on project management.
• The successful candidate will have demonstrated experience in leading cross-functional teams
  

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

• 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.
  

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, 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. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

Moderna is a smoke-free, alcohol-free and drug-free work environment.