Director, 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 in to successful dosage form and commercial product from a pharmaceutical sciences and engineering perspective.  The incumbent will be a part of the leadership team of the Drug Product Development (DPD) group, helping to drive the execution of DP strategy, define and manage the future direction and growth of the organization. This candidate will be responsible for both technical as well as organizational and 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, 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.

• Be a part of the DPD leadership team in charting the future direction and growth of the organization, hiring, resourcing, budget, investments etc.

• 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 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.

• Directly manage 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 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

• 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 10 years (PhD), 14 years (MS), 16 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, including working closely with external CDMOs.

• 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

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 a