Sr. Engineer II, Drug Product Development

4 weeks ago

Norwood, United States Moderna, Inc. Full time

The Role:

This position is part of Modernas Drug Product Development team responsible for ensuring the translation of mRNA technology into successful dosage form and commercial product from a pharmaceutical sciences and engineering perspective. The incumbent will also provide technical leadership and mentoring to the Drug Product Development (DPD) group, helping to drive the execution of DP strategy and develop internal talent.

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 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 development.

Interface closely with Clinical Operations and Early Development organizations to execute and support clinical in-use characterization studies and related documentation.

Interface with MS&T (US and International), External Manufacturing, Quality and Regulatory organizations 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.

Design and execute 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

Support 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 4 years (PhD), 8 years (MS), 10 years (BS) industry experience in biopharmaceutical development

Strong background in first principles modeling for drug product development, to enhance our pharmaceutical design and optimization processes.

Experience serving on or leading cross-functional teams focused on biopharmaceutical development

Experience in parenteral Drug Product development and commercialization, including working closely with external CMOs / CDMOs.

Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities

Prior management and mentorship experience

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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-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.

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 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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