Moderna · 5 hours ago
Senior Manager, Drug Product Technical Operations
Norwood, MA
Full-time
Onsite
Senior Level, Lead/Staff
$131K/yr - $209K/yr
10+ years expModerna is a pioneering company revolutionizing medicine through mRNA technology. The Senior Manager will oversee the Drug Product Technical Operations Specialists team at the Norwood site, ensuring manufacturing readiness and operational excellence across the full drug product lifecycle.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
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
Qualification
Required
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
Preferred
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
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
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-01-24
legacy.thefly.com
2026-01-23
Company data provided by crunchbase