Director, CMC Product Lead

The Role

The CMC Product Lead is a critical strategic role within the CMC organization tasked with the oversight and execution of CMC strategies for multiple assets across therapeutic areas from first in human to pivotal studies. The CMC Product Lead ensures seamless integration of program strategy with the Target Product Profile (TPP) and Quality Target Product Profile (QTPP) and is also responsible for translating Core Team (R&D and/or Commercial) strategies into actionable CMC plans. This role will also be a key interface with our Resilience manufacturing sites. With a comprehensive understanding of drug development the role requires technical expertise leadership skills ability to translate complex messages across multiple altitudes and a robust command of situational complexity and ambiguity to effectively manage CMC plans. The CMC Product Lead is expected to thrive in leading through complex situations demonstrate accountability engage in cross-functional debate and embrace differences in opinion. The ideal candidate will display keen judgment executive presence and the ability to develop self and team members continually.

Heres What Youll Do

• Define and communicate strategic CMC Development Plans for products in a therapeutic area ensuring alignment with the TPP and QTPP.

• Translate platform and program strategy into actionable achievable CMC tasks and milestones prioritizing the portfolio in alignment with enterprise priorities.

• Serve as a key member of Program Team representing CMC and working under the guidance of the Leadership Team (LT).

• Act as the primary point of accountability for the CMC plan making critical decisions and serving as a resource to key leadership.

• Engage in technical discussions own technical roadmap for program implementation and contribute to CMC sections of global regulatory submissions.

• Expert technical storytelling skills across multiple altitudes.

• Lead CMC team in discussions with key leadership R&D teams and internal governance bodies.

• Identify and address cross-functional gaps and risks escalating issues appropriately to drive progress.

• Accountable for the strategy of the resource and financial management of the team including budgeting resource allocation and cost management

• Empower and delegate to team members/workstream leads establishing credibility by diving into the appropriate level of detail when necessary.

• Engage the audience with the right content balancing engagement based on risk and value.

• Build and maintain strong relationships across the organization including with cross-functional stakeholders for facilitating strategic handshakes for effective lifecycle management.

Heres What Youll Need (Basic Qualifications)

• PhD with 10 years MS with 12 years or BS/BA 15 years of relevant experience.

• Proven leadership experience in CMC or product development organizations within the biotechnology/pharmaceutical industry.

• Strong knowledge of CMC-related activities including Technical Development Manufacturing Supply Chain Quality Process Development and CMC Regulatory.

• Demonstrated ability to lead cross-functional teams and complex projects with strategic and operational impact.

Heres What Youll Bring to the Table (Preferred Qualifications)

• PhD in relevant field such as Biochemistry Chemistry Biology Pharmaceutical Sciences

• Proven leadership experience in CMC or product development organizations within the biotechnology/pharmaceutical industry.

• Strong knowledge of CMC-related activities including Technical Development Manufacturing Supply Chain Quality Process Development and CMC Regulatory.

• Demonstrated ability to lead cross-functional teams and complex projects with strategic and operational impact.

• Demonstrates sufficient technical depth in drug development to inform overall CMC strategy

• Financial/business acumen and executive influence with strong stakeholder management skills at all levels.

• Demonstrates leadership quality poise flexibility adaptability and superb written and verbal communication skills.

• Cross-functional influence negotiation skills and a champion of effective decision-making processes.

• Considered a thought leader in program strategy and tactics with the ability to operate through complex and ambiguous situations.

• Comfort navigating ambiguity and leading through change in a dynamic fast-paced environment.

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

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness mindfulness and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown
• Savings and investment opportunities
• 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.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Our Working Model

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.

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

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can 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 .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.