Associate Director, Technical Development
ModernaTX, Inc.

Job Info

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The Role

As the Associate Director of Technical Development, you will play a pivotal role in the CMC Knowledge Management team by innovating our approaches to CMC documentation. This is not just a position; it's a mission for those with a deep passion for high quality technical writing and a visionary outlook on enhancing documentation processes through cutting-edge solutions. Your expertise will help us redefine industry standards, making a tangible impact on our company's future.

Here's What You'll Do

• Leadership & Innovation: Lead by example, inspiring excellence in technical writing within Moderna's CMC organization. Champion innovative practices and technologies, including the application of AI, to streamline and automate CMC documentation processes.
  
• Strategy & Execution: Develop and execute ambitious plans to transform our CMC documentation workflows. This includes creating advanced tools and templates, improving knowledge flow from raw data generation to regulatory submissions, and significantly accelerating our regulatory filing processes.
  
• Collaboration & Influence: Work closely with cross-functional teams of top scientists and engineers in a matrix environment to drive the adoption of best practices and innovative solutions. Your leadership will ensure seamless collaboration and the successful implementation of our strategic documentation roadmap.
  
• Mentorship & Development: Be a mentor and coach to your teams, fostering an environment of learning and growth. Your passion for technical writing will be instrumental in elevating the team's skills and enthusiasm for producing top-notch CMC documentation
  
• Additional duties as may be assigned from time to time
  

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

• 10+ years of experience in process development, manufacturing, analytical sciences, technology transfer or regulatory CMC
  
• BS degree or higher in engineering or biological science
  

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

• A visionary with a solid understanding of CMC documentation, particularly in the biopharmaceutical sector.
  
• Extensive experience with CMC documentation, from the generation of raw data through to regulatory submissions.
  
• Proven leadership and facilitation skills, with the ability to inspire and guide cross-functional teams towards achieving common goals.
  
• Highly collaborative and customer focused.
  
• Strong project management capabilities, adept at creating and executing complex plans with precision.
  
• Passionate about innovation, especially in applying AI and other technologies to enhance documentation processes.
  
• Excellent communication skills, capable of articulating complex concepts clearly and persuasively to a variety of audiences.
  
• 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 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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