Principal Engineer, Drug Product Development
1 month ago
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 contribute to the development of and execution of drug product strategy, contribute to program leadership, staff development and growth of the organization. This candidate will be responsible for both technical as well as matrix 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, packaging development, 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 forModernas portfolio.
Lead matrixed Drug Product teams to advance fill/finish process development, process characterization, primary container / combination product development, packaging development, 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.
Matrix management of 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 drug product applications.
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 8 years (PhD), 12 years (MS), 14 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 of a range of relevant drug product images such as pre-filled syringes, injection devices and vials. Experience working closely with external CDMOs.
Knowledge and understanding of 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%.
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)
-
-
Principal Engineer, Drug Product Development
3 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModernas 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 contribute to the development...
-
Principal Engineer, Drug Product, Global Engineering
3 months ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Principal Engineer, Drug Product, will lead the design development, fabrication, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint for both Clinical and Commercial supply operations. The Principal Engineer will be expected to maintain timeliness, accuracy, and thoroughness...
-
Principal Engineer, Drug Product, Global Engineering
3 months ago
Norwood, United States Moderna, Inc. Full timeThe Role:The Principal Engineer, Drug Product, will lead the design development, fabrication, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint for both Clinical and Commercial supply operations. The Principal Engineer will be expected to maintain timeliness, accuracy, and thoroughness...
-
Engineer I, Drug Product Development
1 month ago
Norwood, United States Moderna, Inc. Full timeThe RoleWe are seeking a highly skilled and motivated Research Associate / Engineer I in Drug Product Development, to work in a team developing Modernas sterile drug product processes and products that enable clinical and future commercial supply. The primary role for this position will be to support product concept development including process development...
-
Director, Drug Product Development
2 months ago
Norwood, United States Moderna, Inc. Full timeThe RoleModernas 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 be a part of the leadership...
-
Sr. Engineer II, Drug Product Development
3 months ago
Norwood, United States Moderna, Inc. Full timeThe 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,...
-
Scientist, Drug Product Development
3 months ago
Norwood, United States Moderna, Inc. Full timeThe RoleModerna is seeking a highly skilled and motivated Scientist or Senior Engineer to join our Drug Product Development (DPD) team in Norwood, MA. To support Modernas exciting pipeline of products, the DPD team works to develop, characterize, and implement robust clinical/commercial manufacturing processes. From pre-clinical through commercialization,...
-
Sr. Engineer II, Drug Product Development
3 months ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe 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,...
-
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Director, Site Digital Lead the Sr. Automation Engineer will support the design, development, startup, and lifecycle of our state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role requires a blend of technical expertise, project management, and cross-functional collaboration across a highly matrixed...
-
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Director, Site Digital Lead the Sr. Automation Engineer will support the design, development, startup, and lifecycle of our state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role requires a blend of technical expertise, project management, and cross-functional collaboration across a highly matrixed...
-
Principal Software Development Engineer
3 weeks ago
Norwood, Massachusetts, United States Moderna Full timeThe Role:ModernaTX, Inc. seeks a Principal Software Development Engineer for its Norwood, Massachusetts location.Here's What You'll Do: Lead Agile software development for custom software solutions enabling the high-throughput synthesis of mRNA through integrated workflows and robotics automation. Serve as technical lead, day-to-day scrum leader, team...
-
Sr. Manager, Validation, Drug Product
3 months ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Associate Director, Validation the Sr. Manager, Validation is responsible for leading Validation readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP,...
-
Sr. Manager, Validation, Drug Product
3 months ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Associate Director, Validation the Sr. Manager, Validation is responsible for leading Validation readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP,...
-
QA Sr. Manager, Drug Product
3 weeks ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Associate Director, QA Drug Product, the QA Sr. Manager, Drug Product Operations is responsible for coordinating and executing the quality and compliance readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and...
-
QA Sr. Manager, Drug Product
1 month ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Associate Director, QA Drug Product, the QA Sr. Manager, Drug Product Operations is responsible for coordinating and executing the quality and compliance readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and...
-
Associate Director, QA Operations, Drug Product
3 months ago
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Director, QA Drug Product, the Associate Director, QA Operations is responsible for leading the quality and compliance readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering...
-
Technical Manager
4 weeks ago
Norwood, United States Eurofins USA Consumer Product Testing Full timeJob DescriptionJob DescriptionCompany DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on,...
-
Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Sr. Director of Sterility Assurance, the Associate Director of Sterility Assurance is tasked with leading the development and management of an aseptic and sterility assurance program for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role encompasses overseeing operational readiness for clinical and...
-
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Sr. Director of Sterility Assurance, the Associate Director of Sterility Assurance is tasked with leading the development and management of an aseptic and sterility assurance program for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role encompasses overseeing operational readiness for clinical and...
-
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna is expanding our footprint to further our mission of delivering the greatest possible impact to people through mRNA medicines Our Norwood, Massachusettss technology hub focuses on software product development for our Research, Clinical, and Manufacturing products and platforms.We are looking to hire experienced Application Development Leads...
