Moderna is seeking a Director to lead cross-functional Technical Development Teams (TDTs) for programs in Modernas late-phase portfolio. In this role, you will be accountable for the definition of end-to-end technical development strategy and will manage the execution of program deliverables through a matrixed team of subject matter experts (SMEs) from Technical Development functional areas.
The Technical Development organization is comprised of scientists, engineers, and problem solvers developing and implementing the most innovative, advanced, and robust platform processes and analytical technologies to deliver Modernas medicines. As the overall technical lead for your programs, you will represent Technical Development within core program teams and partner with leaders across the Chemistry, Manufacturing, and Controls (CMC) and Research and Development (R&D) organizations to ensure program milestones are met throughout late-phase clinical and commercial development.
To be successful in this role, you will work efficiently and cross-functionally across Technical Development and beyond, including with Manufacturing, Manufacturing Sciences and Technology (MS&T), Supply Chain, Finance, Portfolio Operations, Quality, Regulatory, and R&D.
The role is based at the Moderna Technology Center campus in Norwood, MA but may require presence at the Moderna Science Center campus in Cambridge, MA and travel to sites in Modernas global manufacturing network.
Heres What Youll Do:
Leverage strong scientific and engineering background, in collaboration with cross-functional partners and stakeholders, to develop risk-based and phase-appropriate technical development strategies spanning from late-phase clinical development through commercial launch
Drive execution of technical strategy through matrix leadership of cross-functional TDTs, including definition of the pharmaceutical product, development of manufacturing processes and analytical control strategies, technology transfer and process performance qualification (PPQ), and delivery of high-quality CMC sections for regulatory filings to enable late-phase clinical studies and commercial launch
Serve as the accountable leader for all technical and scientific aspects throughout the program development lifecycle, incorporating interdisciplinary scientific knowledge to ensure that technical development strategy and data are supportive of successful registration of pharmaceutical products meeting patient needs
Integrate strategy and data into clear technical narrative for regulatory briefing books, submissions, and interactions. Review and approve content of CMC sections for regulatory submissions
Collaborate effectively and transparently with partners across Moderna to proactively obtain stakeholder endorsement of the technical development strategy to drive successful CMC execution
Communicate technical updates and escalate risks to the TD and CMC leadership teams, and, as appropriate, internal and external partners
Represent Technical Development and present technical content at regular program governance forums and reviews
Mentor and develop TDT SMEs to operate effectively as functional area representatives in cross-functional teams and collaborations
Heres What Youll Bring to the Table:
PhD in Chemical/Biochemical Engineering, Chemistry/Biochemistry, or a related discipline, with 12+ years of technical experience in late-phase/commercial process or analytical development and/or CMC/MS&T, including leadership-level roles
Experience in management of technology transfer, PPQ strategy and execution, and post-approval lifecycle changes is preferred
Mastery in building, leading, and facilitating interdisciplinary teams, with a demonstrated ability to effectively collaborate in dynamic and matrixed environments to build cross-functional consensus
Demonstrated proficiency in authoring high-quality source documents or content for regulatory briefing books and submissions; prior experience in presenting during regulatory interactions, such as pre-submission meetings, is preferred
Deep understanding of the product development lifecycle from R&D through commercial launch, including the interdependencies of technical functions and partner organizations
Effective technical project management in a late-phase clinical/commercial setting, including an ability to set vision by anticipating and balancing the needs of multiple stakeholders
Current knowledge of global regulatory guidance, including US, EU, Japan and ICH
Strong written and oral communication skills
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!
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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. Were 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 firstname.lastname@example.org. (EEO/AAP Employer)