Cmc Jobs in Kentucky (NOW HIRING)

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.

• 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.

• 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.

• PhD in relevant field such as Biochemistry, Chemistry, Biology, Pharmaceutical Sciences
• 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. That's why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, 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 investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $183,800.00 - $330,300.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

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

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 a place where everyone can grow.

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

We're 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 leavesandaccommodations@modernatx.com.

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 applicant's ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company's ability to obtain any required export control license.