Specialist, New Product Introduction

The Role:

Moderna is seeking a Specialist for the New Product Introduction team within Clinical Drug Substance. This role will be based at the Norwood, MA site. As a leader of NPI, he/she will apply expert knowledge of manufacturing practices, bioprocess unit operations and cGMPs to enable success with new product and process introductions while maintaining safety and compliance at the forefront. The NPI Lead will be a key player in the development of operational procedures, leading tech transfer activities, process improvements and driving right first-time results for new suites, equipment, and processes. This individual will lead operational introduction of new DS processes into MTC-S. This specialist will support deployment of the overall drug substance technical strategic roadmap.

Here’s What You’ll Do:

• Creates and manages results of improvement projects, right first-time activities and batch completion reviews
• Participate in equipment start-up, commissioning, and validation activities as required
• Drive operational readiness activities for new processes and products with water runs, right first-time preparation, introduction to manufacturing presentations
• Maintain a flexible schedule based on the demands of production and projects
• Project manage process and equipment technical transfers from development and technology partners
• Leverage Lean and Six Sigma principles to foster and drive a culture of continuous improvement
• Own and manage change controls for projects within the team
• Participate and drive cross-functional teams to initiate and maintain complex manufacturing operational changes, improvements to existing processes and new product introductions
• Provide on-the-floor support to the manufacturing team in execution of new processes, equipment, troubleshooting issues, and safety practices
• Practice and promote safe work habits- adhere to all safety procedures and guidelines

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

• A self-driven mindset who can work independently and as a team with minimal supervision and direction
• Demonstrated ability to lead, communicate and present data
• Experience with MES, SAP and VEEVA highly preferred
• Demonstrated track record of complex problem solving and trouble-shooting technical and process related issues
• Highly organized with proven project management skills
• A BS in engineering or sciences and minimum of 2-4 years of highly relevant experience in manufacturing processes in a pharmaceutical or biotechnology environment.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

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

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 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)

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