Director, Drug Product Operations, Formulation and Filling

The Role

As the Director of Drug Product Operations (Formulation and Filling) at Moderna, you have a key leadership role responsible for overseeing the formulation and filling of aseptically manufactured drug products at a new state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products in vials and pre-filled syringes. The Director will play a crucial role in establishing the operational strategy, implementing best practices, and building a team to achieve excellence in manufacturing operations while adhering to regulatory compliance and quality standards. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Here’s What You’ll Do

In this role, your responsibilities will include:

• Develop and execute Operational readiness strategies to ensure the successful launch and ongoing production of aseptic drug products, including labeled drug products.

• Establish robust operational readiness plans to transition from the construction phase to full-scale production, ensuring all systems and processes are in place for cGMP compliance.

• Oversee the hiring, training, and development of a high-performing operations team capable of executing complex aseptic processes across multiple Drug Product filling lines.

• Collaborate with cross-functional teams working in a highly matrixed environment to drive decisions and influence outcomes to enable Moderna’s clinical pipeline.

• Drive continuous improvement initiatives to enhance operational efficiency, reduce costs, and improve product quality.

• Develop and manage the operational budget, including capital expenditure planning and cost control measures.

• Lead risk management activities to identify potential operational issues and implement mitigation strategies.

• Ensure adherence to all environmental, health, and safety guidelines, promoting a culture of safety within the operations team.

• Establish key performance indicators (KPIs) to measure and report on operational performance, making data-driven decisions to optimize processes.

• Foster a culture of innovation and collaboration, encouraging team members to contribute ideas for process improvements and operational excellence.

• Serve as the primary point of contact for operations during regulatory inspections and audits.

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

• Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related technology discipline.

• A minimum of 10 years of experience in aseptic drug product manufacturing, with at least 5 years in a leadership role.

• Proven track record of successful facility start-ups or major operational projects (e.g., Greenfield or Brownfield Projects) within the pharmaceutical industry.

• Experience working with Single-Use-Mixing systems.

• Experience working with Optima and IMA drug product filling lines utilizing isolator technology.

• Experience with drug product lyophilization, liquid vial filling and pre-filled syringes.

• In-depth knowledge of cGMP regulations, aseptic processing, and cleanroom operations.

• Strong leadership skills with the ability to develop and motivate a diverse team.

• Excellent project management, organizational, and communication skills.

• Problem-solving mindset with a commitment to quality and safety.

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

• Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders, with the ability to convey complex information in an understandable manner to various stakeholders.

• Operational experience managing temperature sensitive products including end-to-end cold chain management.

• Experience with budget management and cost optimization in a manufacturing environment.

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

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in person