Senior Manager, Drug Product Technical Operations

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 in Norwood, Massachusetts — a cornerstone of our manufacturing operations. This site plays a critical role in our end-to-end drug product supply, from component preparation to aseptic filling and packaging. At Norwood, you’ll be immersed in a high-energy environment of innovation, working hands-on to deliver our mRNA medicines to the world.

This highly visible leadership role will oversee Moderna’s Drug Product Technical Operations Specialists team at the Norwood site, ensuring manufacturing readiness and operational excellence across the full drug product lifecycle — from component preparation to packaging. As Director, you’ll lead all aspects of new product introductions, eBR/MES governance, SOP and deviation quality systems, inspection readiness, and innovative AI/GPT-driven operational efficiency initiatives. This is a hands-on leadership role embedded in daily operations, requiring technical acumen, strategic foresight, and the ability to build a high-performing team.

Here's What You’ll Do:

Your key responsibilities will be:

• Build, lead, and coach a high-performing Technical Operations Specialists team with a strong focus on culture, performance, inclusion, and succession.

• Ensure day-to-day manufacturing support with real-time coaching on cGMP, safety, and technical execution.

• Lead all operational readiness activities for new product introductions and tech transfers, including process recipes, master data, components, and sampling plans.

• Partner with cross-functional teams (MS&T, QA, Engineering, Supply Chain) to align on validation readiness, process design, and launch timelines.

• Own and govern all aspects of eBR/MES systems, including master batch records, recipes, change management, data integrity, and error reduction.

Your responsibilities will also include:

• Drive and oversee the responsible development and use of GPT/AI-based tools and automations to reduce cycle time and human error, such as documentation assistants, line setup guides, and KPI dashboards.

• Sponsor the governance, validation, and risk management frameworks required for AI/GPT adoption; track ROI and user adoption.

• Maintain best-in-class standards in deviations, change controls, risk assessments, sampling plans, and CAPA closure with high technical quality.

• Ensure inspection readiness through strong evidence packs, storyboards, and team SME preparedness; participate in mock audits and close gaps proactively.

• Align all operational controls and documentation with evolving regulatory requirements to mitigate quality events.

• Lead KPI reviews and performance monitoring (SQDCP), tiered governance, and root cause resolution of systemic constraints.

• Act as an operations excellence catalyst—driving Lean/Six Sigma, 5S, kaizen workshops, standard work, and digital analytics scaling across teams.

• Provide flexible coverage, including 24/7 on-call support as needed to troubleshoot issues, resolve unclear instructions, or mitigate production risks.

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

• We behave like owners. This role directly influences batch delivery, inspection readiness, and launch success — requiring an ownership mindset to lead across boundaries and elevate standards daily.

• We digitize everywhere possible using the power of code to maximize our impact on patients. You will champion the integration of Generative AI and digital tools into GMP operations, pioneering novel ways to reduce complexity, eliminate manual steps, and boost operational excellence.

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

• Education: Bachelors Degree in Engineering or Life Sciences

• Experience: 10-12 years in cGMP pharmaceutical manufacturing, with direct, hands-on experience in:

  • Component preparation and formulation

  • Aseptic filling operations using isolators and decontamination

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