Sr. Engineer I, INT DNA, Manufacturing Science and Technology

The Role:

This position supports the technical transfer of a novel cancer therapeutic drug, Individualized Neoantigen Therapy (INT), from technical development into Moderna’s cGMP manufacturing site in Marlborough.    Reporting to the Director of MST, the Sr. Engineer I will be responsible for performing and managing technology transfers of new processes, materials, consumables, buffers, equipment in support of manufacturing.

Here’s What You’ll Do:

• Lead cross functional Technology Transfer teams and Investigation teams.  Track and coordinate project milestones to enable cGMP compliant implementation.

• Work with Manufacturing, Facilities, Digital, and Quality to implement additional production trains.

• Partner with Technical Development, Manufacturing, Digital and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.

• Be the subject matter expert for drug substance, and lipid nanoparticle processes.  This includes supporting equipment commissioning/validation, process transfer, MES implementation, troubleshooting, and leading technical investigations.

• Author process descriptions, technology transfer documents, deviation/investigation reports, technical reports, and manage technical CAPA/change controls.

• Review process performance trending / metrics using digital information and statistical analysis tools and improve the process based on that analysis.

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

• Biochemical engineer, Chemical engineer, or Biochemistry background. Ph.D. with 0-2 years experience or MS with 6+ years experience or BS with 8+ years of experience in a pharmaceutical or biotechnology company. Advanced degree preferred (MS, Ph.D.)

• Prior leadership experience managing MST, Process Development, or Technical Development groups or function for a pharmaceutical or biotechnology company.  Demonstrated ability to mentor and develop a technical staff.

• Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI).

• Extensive knowledge of quality systems, cGMP, and industry standards at all phases of drug development.

• Preferred: Knowledge of digital cGMP tools.  For example: SAP, OSI PI, MES (eBR), Unicorn, eQMS

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 f