Sr. Specialist, Drug Product, MS&T

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is solidifying its footprint within our international center for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts.

In this newly created position, you will have the unique opportunity to shape the technical support of external drug product manufacturing operations in Europe, reporting directly to the Drug Product Manufacturing Science Technology leader at Moderna. This role is critical in supporting our commercial GMP production at Fill Finish Contract Manufacturing Organizations (FF CMOs) across the region.

Here’s What You’ll Do

Your key responsibilities will be:

• Supporting the Drug Product Manufacturing Science leader in tasks related to the technical support of commercial GMP production.

• Acting as a counterpart for the commercial technical support team to ensure on-time and in-full deliveries.

• Partnering with Quality, Technical Development, Manufacturing Operation, and Regulatory colleagues on specific aspects of the relationships with the FF CMOs.

• Ensuring that all externally manufactured drug products are produced and stored according to the required documentation, achieving the necessary quality standards.

Your responsibilities will also include:

• Coordinating with external operation teams to meet operational activities at the FF CMOs according to Moderna’s standards (Compliance, Meeting Orders, Dispute resolution, Production Planning, Materials Management, Technology Issues, OpEx).

• Leading continuous improvement initiatives and driving implementation at FF CMOs.

• Monitoring Key Performance Indicators and supporting the preparation of periodic business and operations review meetings.

• Frequently visiting and maintaining presence at the external partners’ sites to build strong interdependent relationships.

The key Moderna Mindsets you’ll need to succeed in the role:

• Pursue options in parallel: This role requires a proactive approach to managing multiple tasks and projects in a fast-paced environment, ensuring efficient and effective outcomes.

• Prioritize the platform: You will focus on leveraging and enhancing our mRNA platform to maximize impact on patient health.

Here’s What You’ll Need (Basic Qualifications)

• Bachelor's Degree with 5-8 years of technical experience in biopharmaceutical industry or a Master’s Degree with 2-5 years biopharmaceutical industry experience; Degree in Engineering or Life Sciences is preferred

• Fluency in English and Spanish are required

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Good communication skills (verbal and written) to collaborate with other CMC team members and managers in a dynamic, cross-functional matrix environment

• Ability to work with members of partner organizations (CMOs)

• Well organized – a natural ability to be organized in how you think, communicate and conduct your work

• You drive for results – you set a high bar for yourself and others

• Good critical thinker that can anticipate the needed next step and therefore can work independently

• A curious mindset that allows you to constantly learn and challenge the status quo

• Ability to navigate through ambiguity and rapid growth and adapt to change.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

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