drjobs Manager, CMC Program Management

Manager, CMC Program Management

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1 Vacancy
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Job Location drjobs

Norwood, OH - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

The Role

The CMC Program Management team in Technical Development seeks a Manager to perform pivotal work focusing on the comprehensive management of integrated project plans for CMC programs. The candidate is expected to enable cross-functional communication aligning priorities for optimal project execution while demonstrating the ability to impact drug development projects. The ideal candidate will have a background in science with prior experience in Manufacturing Quality Process Development and/or Supply Chain organizations. This is an onsite role based in Modernas Technology Center campus in Norwood MA.

You will leverage previous product development and commercialization experience acting as an integrating conduit between CMC functional groups in close collaboration with the CMC Pipeline Team Lead and Team members. Your efforts will ensure seamless execution and management of program(s) with a focus on operational planning risk management budget oversight and timely submissions of reports and updates. You will facilitate cross-functional communication and lead the execution of product strategies from discovery through clinical development and commercialization.

Heres What Youll Do

  • Leverage previous experience within CMC product development and commercialization to integrate between multiple functional areas including Technical Development Manufacturing Regulatory Quality and Supply Chain.

  • Oversee the CMC project plan to align with program goals and ensure timely execution.

  • Develop project plans that integrate cross-functional inputs and support strategy execution.

  • Manage the risk register by identifying risks and implementing mitigation strategies.

  • Ensure action items from team meetings are completed upholding team accountability.

  • Organize and lead team meetings producing concise materials to communicate key points.

  • Provide data analysis to support strategic decisions and direction setting.

  • Track project milestones report progress and keep stakeholders informed.

  • Formulate plans for risk mitigation and scenario planning for potential challenges and opportunities.

  • Oversee project budgets ensuring alignment with financial objectives.

  • Lead Project Management processes including technical and reviews goal setting and commercialization strategies.

  • Contribute to the enhancement of Project Management practices for organizational effectiveness.

Heres What Youll Need (Basic Qualifications)

  • Education: Bachelors or Masters in Life Sciences Chemistry Engineering Pharmaceutical Sciences or related technical discipline

  • Experience: 8 years of relevant experience with a Bachelors degree or 6 years of relevant experience with a Masters degree

Heres What Youll Bring to the Table (Preferred Qualifications)

  • Project Management Professional (PMP) certification is preferred.

  • Previous experience with CMC product development and commercialization is preferred.

  • Familiarity with CMC technical processes and the overall drug development process.

  • Strong project management skills with an agile approach to system development.

  • Strong communication skills.

  • Experience in risk register maintenance and action log management.

  • Proficiency in facilitating meetings and drafting presentation materials.

  • Ability to lead contingency planning and scenario analyses.

  • Advanced PowerPoint and SmartSheet or MS Project skills.

  • Evidence of problem-solving and innovative thinking to deliver creative solutions.

  • Ability to work collaboratively on multiple projects concurrently in a fast-paced environment.

  • Excellent organizational communication and analytical skills with a keen attention to detail.

  • Outstanding interpersonal skills to form and maintain strong relationships.

  • Willingness and dedication to go above and beyond in pursuit of team goals.

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.

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Required Experience:

Manager

Employment Type

Full-Time

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