Senior Director, MSAT

** We digitize everywhere possible using the power of code to maximize our impact on patients.
** This role is deeply embedded in the transformation of Drug Product operations through data science, AI/ML, and automation. Your success will come from leveraging digital tools to enhance manufacturing performance, integrity, and scalability.
** We behave like owners. The solutions we’re building go beyond any job description.
** This is a role that spans internal and external networks, regulatory accountability, team development, and manufacturing innovation. Ownership of outcomes, not just deliverables, is essential to delivering Moderna’s mRNA medicines globally and reliably.
* M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.)
* A minimum of 15 years related work experience
* Filling process development, optimization, and validation.
* Visual inspection technologies (manual and robotic).
* Process validation, EMPQ, and media fills.
* Regulatory compliance and contributions to PPQ and BLA filings.
* Familiarity with global regulatory guidelines (CFR 21, ICH, PDA standards).
* Proficiency in Continued Process Verification (CPV), Quality by Design (QbD), and data analytics tools.
* Familiarity with labeling and packaging processes.
* Experience with AI (ChatGPT preferred) and data analysis tools (JMP)
* Intellectual curiosity and ability to lead and mentor staff in technical areas outside your area of expertise.  Ability to influence cross functionally.
* Demonstrated experience implementing new technology for commercial operations
* Strong technical problem-solving experience
* Effective collaboration and stakeholder management. Ability to influence internally and externally (suppliers), including negotiation.
* Excellent verbal and written communication skills for regulatory submissions, inspection support, and technical presentations.
* Ability to effectively communicate complex technical topics and develop strategic scenarios to stakeholders and senior leadership.
* 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
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