Sr. Engineer II, Drug Product Development

The Role:

This position is part of Moderna’s Drug Product Development team responsible for ensuring the translation of mRNA technology into successful dosage form and commercial product from a pharmaceutical sciences and engineering perspective.  The incumbent will also provide technical leadership and mentoring to the Drug Product Development (DPD) group, helping to drive the execution of DP strategy and develop internal talent.

From pre-clinical through commercialization, DPD is accountable for product image definition, formulation development, aseptic process development and characterization, container science, process scale up, and technology transfer through validation. Our team’s goal is to develop, characterize, and implement robust clinical/commercial manufacturing processes for parenteral products.

Here’s What You’ll Do:

• Lead matrixed Drug Product teams to advance formulation development, fill/finish process development, process characterization, technology transfer, and regulatory authoring of our mRNA portfolio candidates in development.

• Interface closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation.

• Interface with MS&T (US and International), External Manufacturing, Quality and Regulatory organizations to develop and execute on strategies for commercialization of late-stage programs.

• Collaborate with key stakeholders (Clinical Operations, Quality, Compliance, Analytical, MS&T, Regulatory etc.) to optimize our business processes maximizing agility and consistency.

• Design and execute detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and understand DPD processes.

• Provide technical mentorship to junior scientists/engineers in all aspects of parenteral drug product development and aseptic processing.

• Advance platform and functional initiatives through direct contributions and matrixed leadership

• Support authoring and review of regulatory submissions.

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

• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline

• Minimum of 4 years (PhD), 8 years (MS), 10 years (BS) industry experience in biopharmaceutical development

• Strong background in first principles modeling for drug product development, to enhance our pharmaceutical design and optimization processes.

• Experience serving on or leading cross-functional teams focused on biopharmaceutical development

• Experience in parenteral Drug Product development and commercialization, including working closely with external CMOs / CDMOs.

• Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities

• Prior management and mentorship experience

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 wo