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 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 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. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit /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 contact the Accommodations team at . (EEO/AAP Employer)

Created: 2024-10-26