Senior Manager, Drug Product Technical Operations

Moderna • Norwood, MA

6d • Onsite

About The Position

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.

Requirements

• 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
• Media fills and product transfers
• Filling line operations (e.g., Optima)
• Specific Certifications or Training: Strong understanding of regulatory expectations for inspection, labeling, and packaging (FDA, EMA, etc.).
• This position is site-based, requiring you to be at Moderna’s site full-time.
• This position is not eligible for remote work.

Nice To Haves

• Experience leading or supporting tech transfers, process improvements, and equipment start-ups in a manufacturing environment.
• Familiarity with MES systems, batch record execution, and deviation/CAPA processes.
• Proven ability to supervise and coach staff, troubleshoot in real time, and drive operational results.
• Excellent written and verbal communication skills; able to interact effectively across functions and levels.
• Strong problem-solving, decision-making, and organizational skills with a continuous improvement mindset.
• Knowledgeable in media fills, aseptic filling, isolators, Optima lines, and VHP decontamination processes.

Responsibilities

• 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.
• 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.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees