The Role:

The Executive Director of CMC Portfolio Operations and Commercialization is a senior leadership role responsible for overseeing all Chemistry, Manufacturing, and Controls (CMC) activities related to the portfolio management, late-stage development, and commercial readiness of pharmaceutical products. This position plays a critical role in guiding the strategic direction and operational execution of CMC functions to ensure successful product launches and compliance with global regulatory standards. As a key member of the Technical Development Leadership Team, the Executive Director collaborates closely with senior leadership to ensure that CMC strategies are aligned with corporate objectives and efficiently integrated across the product lifecycle.

Here's What You’ll Do:

• Strategic Leadership in CMC Portfolio Management: Lead the strategic planning and execution of CMC activities for products through commercialization, managing and reporting on the overall portfolio of all development programs in alignment with the Development Operating Model.

• Collaboration with Value Chain Management: Develop and maintain a strong collaborative relationship with the Value Chain Management team. This includes initiating and facilitating strategic handshakes between the CMC teams and Value Chain Management, which are essential for ensuring effective lifecycle management of products.

• Collaboration with CMC Development Teams: Coordinate closely with the Senior Director of CMC Development to ensure seamless progression of projects from CMC development to late-stage development and commercial readiness. This role will consolidate and report activities to ensure comprehensive oversight across all stages of CMC development.

• Cross-functional Collaboration: Work with cross-functional leaders in Clinical Development, Regulatory Affairs, Quality Assurance, and Manufacturing to ensure a seamless transition from development to commercial manufacturing.

• Comprehensive Risk Management: Develop and implement comprehensive risk management strategies to address potential challenges in product development and commercialization timelines.

• Leadership and Team Development: Mentor and lead a team of CMC professionals, fostering a culture of innovation, operational excellence, and continuous improvement.

• Financial and Resource Management: Direct the financial management of the CMC Commercialization portfolio, including budgeting, resource allocation, and cost management.

• Adaptation to Industry Changes: Stay informed on the latest industry trends, technological advancements, and regulatory updates to effectively adapt CMC strategies.

Here’s What You’ll Bring to the Table:

• Demonstrated leadership and strategic management capabilities with extensive experience in CMC operations within the biopharmaceutical industry.

• A proven track record of effectively managing a CMC Portfolio, demonstrating strategic oversight and tactical execution in aligning complex project demands with overarching product and portfolio development goals. Expertise in driving product advancement from development through commercialization within a regulated biopharmaceutical environment is essential.

• Possess technical knowledge and experience of drug development processes to make informed decisions on critical technical strategies. Ensure accountability for these strategies' effectiveness to meet the CMC Portfolio deliverables.

• Deep understanding of the global regulatory landscape and quality standards critical to pharmaceutical product development and commercial manufacturing.

• Strong communication, negotiation, and interpersonal skills, capable of influencing and collaborating with stakeholders across all organizational levels.

• Proven ability to make strategic decisions in complex and dynamic environments.

• Excellent problem-solving skills and adaptability to meet changing project requirements and business needs.

Experience:

• Minimum of 15 years of experience in the biopharmaceutical industry, including 5 years in a leadership role managing CMC functions for late-stage or commercial products. A track record of leading successful regulatory submissions and product launches.

Educational Requirements:

• Required: Advanced degree (PhD or Master’s) in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or a related scientific/engineering discipline.

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 personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ community
• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) 

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