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Fellow, Drug Product Development

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Dec 4, 2023

Job Details

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 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 Modernas 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 teams goal is to develop, characterize, and implement robust clinical/commercial manufacturing processes for parenteral products.

Heres What Youll Do:

  • Lead, develop, inspire and mentor a group of scientists and engineers in support of DPD goals for Modernas portfolio.

  • Be a part of the DPD leadership team in charting the future direction and growth of the organization, hiring, resourcing, budget, investments etc.

  • 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.

  • 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.

  • 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

  • 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

Heres What Youll Bring to the Table:

  • Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline

  • Minimum of 10 years (PhD), 14 years (MS), 16 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, including working closely with external CDMOs.

  • 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

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, 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

#LI-AG1

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Telephone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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