Sr. Engineer I

The Role

Moderna is seeking a highly skilled and motivated Senior Engineer I or Scientist to join our Drug Product Development (DPD) team in Norwood, MA. To support Moderna’s exciting pipeline of products, the DPD team works to develop, characterize, and implement robust clinical/commercial manufacturing processes. From pre-clinical through commercialization, DPD is accountable for product image definition, formulation development, process development, characterization and scale up as well as technology transfer. The focus of this role will be supporting product development and program progression through planning and executing studies in the laboratory, and the authoring of protocols, reports and regulatory documentation.

Here’s What You’ll Do

• Lead design, execution, documentation, and presentation of relevant experimentation to support Drug Product teams in advancing fill/finish process development, container development, process characterization, packaging development, technology transfer, and regulatory authoring of our mRNA portfolio candidates.

• Design and execute detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and troubleshoot specific unit operations.

• Author and review technical protocols, reports, product impact assessments, and regulatory sections as required in support of IND and marketing application submissions.

• Enable development of container closure options for Moderna clinical and commercial products by establishing test protocols and procedures as well as partnerships with external partners as required.

• Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects.

• Lead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables.

• Support authoring and review of regulatory submissions.

Here’s What You’ll Bring to the Table

• BS (6+ years), MS (4+ years) or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry or related scientific disciplines with direct industry experience in small and/or large molecule parenteral drug product development.

• Exceptional laboratory skills and hands-on experience with aseptic liquid filling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems and packaging systems.

• Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.

• Ability to perform data analysis using advanced statistical, including design of experiments (DoE) approaches leveraging statistical analysis software.

• Experience with first principle model development, heat / mass transfer and computational fluid dynamics.

• Experience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.

• Knowledge of GMP and GLP compliance.

• Ability to travel up to 20%.

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 c