Sr. Engineer I, 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 centre 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.

This Sr. Engineer position is part of the Drug Product (DP) Moderna’s Manufacturing Science and Technology (MST) team, tasked with technical support of GMP operations across international and US sites. Working under the guidance of the Director, you will play a crucial role in liaising with DP Contract Manufacturing Organizations (CMOs) and Moderna sites to drive forward the portfolio of projects and initiatives supporting commercial lifecycle management, technology transfer, and drug product technologies.

Here's What You’ll Bring to the Table:

Your key responsibilities will be:

• Supporting continuous improvement initiatives and complex technical projects for DP and Aseptic manufacturing operations globally.

• Collaborating with Moderna’s DP Operations to establish robust and compliant manufacturing performance at drug product CMOs.

• Partnering with Technical development to investigate and resolve complex manufacturing issues at CMOs.

Your responsibilities will also include:

• Writing or revising the appropriate GMP documentations.

• Automating, visualizing, and analyzing QC data and metrics, identifying trends and patterns, analyzing causality, formulating improvement proposals, and converting the insights with business teams to actions and plans for measurable business improvements.

• Representing MST as a subject matter expert (SME) on DP manufacturing data analysis with Digital, Operations, and Technical Development teams.

• Contributing to our process data management and overall knowledge management strategy.

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

• Prioritize the platform: Your work prioritizes our platform of mRNA technology, ensuring that every effort is aimed at enhancing our capability to deliver outstanding results.

• Act with dynamic range: You’ll need the ability to drive both strategy and execution simultaneously, adapting to new data and changing contexts swiftly and effectively.

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

• MS or equivalent in a scientific, engineering or mathematical discipline with 5+ years’ experience in the pharmaceutical industry, Ph.D level with 0+ years’ experience.  BS applicants with 8+ years’ relevant experience will also be considered.

• Proficiency in English required

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

• Prior experience in aseptic manufacturing

• Prior experience with DP operations and/or and Laboratory Instruments

• Prior experience working in a GMP environment.

• Technical agility.  The capability to manage, and work with, diverse technical teams.

• The ability to collaborate effectively in a dynamic, cross-functional matrix environment.

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

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

• Preferred: Strong experience in creating statistical analysis models.  Use of statistical programs for DOE analyses, multivariate analysis, and statistical process control.

• Subject matter expertise on statistical best practices

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

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 apprec