Principal Research Associate, Drug Product Development

The Role

Moderna is seeking a highly skilled and motivated Scientist or Engineer to join our Respiratory 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

• Enable drug product development and execute analytical development studies in respiratory space with a focus on phase appropriate method qualification. This will involve working closely with various internal and external analytical groups to assess test method readiness.

• Design, execute, and document studies to characterize and/or scale-up operations (freeze/thaw, mixing, filtration, filling, visual inspection, etc.).

• Develop approaches and execute studies to evaluate the compatibility of Drug Product with processing materials, container closure components, and sterilization processes.

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

• Maintain meticulous records through ELN and report authoring to ensure documentation compliance in support of cGMP activities.

• Lead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables with a focus on respiratory delivery.

• Support authoring and review of regulatory submissions.

• Additional duties as may be assigned from time to time

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

• Bachelor’s or Master’s Degree in Chemical / Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with a minimum of 5 (Bachelor’s) or 3 (Master’s) years industry experience in biopharmaceutical development.

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

• Exceptional laboratory skills and demonstrated knowledge in operation characterization and scale up, with an ability to multitask.

• Experience with analytical characterization and respiratory analytical methods and testing.

• Candidate will be curious in understanding key scientific questions and tailoring analytical assays to answer them, and bold in trying new analytical approaches. Ability work collaboratively with multifunctional teams and will be relentless in solving technical problems of separation and detection

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

• Experience with GMP and GLP compliance and process validation

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

• 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 perk