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 lead a device and secondary packaging development group as part of the Drug Product Development (DPD) leadership team. The lead will have oversight of combination product development, primary container development, shipping validation and secondary packaging development activities for Moderna products for global markets. Activities include design validation, human factors engineering validation, package design, qualification, and support of regulatory filings. This candidate will be responsible for both technical and organizational leadership aspects of combination product development, to advance Moderna’s exciting mRNA pipeline and technology platforms.
Here’s What You’ll Do
- Lead, develop, inspire and mentor a group of scientists and engineers focused on developing container, device and combination products, shipping solutions and developing robust packaging solutions for Moderna’s product portfolio.
- Provide technical oversight for the design, execution, and documentation of appropriate device development, verification, and validation studies, design history file generation and human factors engineering validation activities and documentation.
- Provide scientific and technical packaging expertise and oversight for the design and development of robust packaging systems including packaging component definition and process definition.
- Review and approve the secondary packaging component specifications, test procedures, manufacturing procedures, and equipment qualification protocols and reports as per site requirements.
- Provide scientific and technical leadership in the development of primary container systems, inclusive of container closure integrity testing, extractable / leachable analysis and assessment of glass delamination.
- Lead matrixed Drug Product teams to advance development initiatives and implementation.
- Be a part of the DPD leadership team and contribute to charting the future direction and growth of the organization, hiring, resourcing, budget, investments etc.
- Interface with and influence key stakeholder organizations including MS&T (US and International), External Manufacturing, Artwork, Quality and Regulatory to develop and execute on strategies for commercialization of late-stage programs.
- Directly manage a team of Scientists and Engineers facilitating personnel growth, development and subject matter expertise. Provide technical mentorship to junior scientists/engineers.
- Advance platform and functional initiatives through direct contributions and matrixed leadership.
- Drive authoring and review of regulatory submissions.
Here’s What You’ll Need (Basic Qualifications)
- Degree in Chemical/Biomedical/Mechanical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline.
- Minimum of 10 years (PhD), 14 years (MS), 16 years (BS) industry experience in biopharmaceutical development.
Here’s What You’ll Bring To The Table
- Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas.
- Demonstrated expertise working with a range of biopharmaceutically relevant containers and devices such as vials, pre-filled syringes, injection devices and respiratory delivery devices.
- Experience in combination product device development and commercialization, including working closely with external CDMOs.
- Experience leading the medical device design control and development process, including risk management, design transfer and sustaining manufacturing / engineering activities.
- Experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820 or ISO 13485) and ISO 14791 requirements.
- Understanding of global industry standards (ex. ISO, ASTM, etc.) and working knowledge of the medical device regulatory environment and applicable regulations.
- Knowledge and understanding of material manufacturing and converting, 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%.
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
- Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
- Lifestyle Spending Accounts to personalize your well-being journey
- Family planning and adoption benefits
- Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
- Savings and investment opportunities
- 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 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 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 consider qualified applicants regardless of criminal histories, consistent with legal requirements.
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 leavesandaccommodations@modernatx.com. (EEO Employer)
