Fellow, 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 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.
• Advance platform and functional initiatives through direct contributions and matrixed leadership
• 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.
• Lead, develop, inspire and mentor a group of scientists and engineers in support of DPD goals for Moderna’s portfolio.
• Interface closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation.
• 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
• Drive authoring and review of regulatory submissions
• Be a part of the DPD leadership team in charting the future direction and growth of the organization, hiring, resourcing, budget, investments etc.
• Provide technical mentorship to junior scientists/engineers in all aspects of parenteral drug product development and aseptic processing
• Collaborate with key stakeholders (Clinical Operations, Quality, Compliance, Analytical, MS&T, Regulatory etc.) to optimize our business processes maximizing agility and consistency.

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

• Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities
• Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline
• Experience in parenteral Drug Product development and commercialization, including working closely with external CDMOs.
• Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas
• Prior management and mentorship experience; passion for people management and development
• Minimum of 10 years (PhD), 14 years (MS), 16 years (BS) industry experience in biopharmaceutical development

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Discretionary year-end shutdown
• Free premium access to fitness, nutrition, and mindfulness classes
• Dedicated care coordination support for our LGBTQ+ community
• Highly competitive and inclusive medical, dental and vision coverage options
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Location-specific perks and extras!
• Paid sabbatical after 5 years; every 3 years thereafter
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Vacation, sick time and holidays
• Adoption and family-planning benefits
• Volunteer time to participate within your community
• 401k match and Financial Planning tools
• Free parking or subsidized commuter passes
• Generous paid time off, including:
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Exclusive preferred pricing on Peloton fitness equipment
• Complimentary concierge service including home services research, travel booking, and entertainment requests

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 world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)

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