Principal Engineer, Drug Product Development

The Role

Moderna’s Drug Product Development team is seeking an experienced, innovative and accomplished leader. Drug product development is responsible for ensuring the translation of mRNA technology into successful dosage forms and commercial products from a pharmaceutical sciences and engineering perspective. The incumbent will contribute to the development of and execution of drug product strategy, contribute to program leadership, staff development and growth of the organization. This candidate will be responsible for both technical as well as matrix team leadership to advance Moderna’s exciting mRNA pipeline and technology platforms.

From pre-clinical through commercialization, DPD is accountable for product image definition, formulation development, aseptic process development and characterization, container science, packaging development, 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, develop, inspire and mentor a group of scientists and engineers in support of DPD goals for Moderna’s portfolio.

• Lead matrixed Drug Product teams to advance fill/finish process development, process characterization, primary container / combination product development, packaging development, technology transfer, and regulatory authoring of our mRNA portfolio candidates in late-stage development.

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

• Interface with and influence key stakeholder organizations including MS&T (US and International), External Manufacturing, Quality and Regulatory 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.

• Matrix management of a team of Scientists and Engineers responsible for the design and execution of detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and understand drug product applications.

• 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.

• Drive 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 8 years (PhD), 12 years (MS), 14 years (BS) industry experience in biopharmaceutical development

• Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas.

• Experience in parenteral Drug Product development and commercialization of a range of relevant drug product images such as pre-filled syringes, injection devices and vials. Experience working closely with external CDMOs.

• Knowledge and understanding of product/packaging interaction, barrier properties, stability, global pharmaceutical packaging regulations, and package testing.

• Prior management and mentorship experience; passion for people management and development

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

• 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
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