Director Drug Product Development

The Role

Modernas 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 Modernas exciting mRNA pipeline and technology platforms.

Heres What Youll 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 Modernas product portfolio.

• Provide technical oversight for the design 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 latestage 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.

Heres What Youll 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.

Heres What Youll 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 prefilled 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 fastpaced 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. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.

• Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to wellbeing with access to fitness mindfulness and mental health support
• Lifestyle Spending Accounts to personalize your wellbeing journey
• Family planning and adoption benefits
• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
• Savings and investment opportunities
• Locationspecific 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 worldclass 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 nondiscrimination for all employees and qualified applicants without regard to a persons 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 EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were 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 . (EEO Employer)