The Role:Moderna is seeking a highly skilled and motivated Senior Engineer to join our Drug Product Development (DPD) team in Norwood, MA, to support development of Moderna's device combination products. The primary role for this position will be to support drug product development activities including: device development, combination product development and packaging development. Specifically, the applicant will be responsible for Human Factors Engineering activities related to Moderna's combination products. Applicants should have relevant device engineering related experience in the pharmaceutical space. The applicant should have exceptional ability to plan, execute and report, to communicate and collaborate, and requires strong attention to detail while working in a fast-paced, interdisciplinary environment.Here's What You'll Do:Lead human factors engineering activities on drug delivery device technology development and/or drug-device combination product programs.Be involved in problem solving and utilization of different strategies to support resolution of design, risk and regulatory challenges.Help establish and develop of human factors engineering strategies for drug delivery combination product.Ensure user needs are considered early and continuously throughout the design process.Manage and support the execution of early patient handling studies, identify and maintenance of user needs, conduct user related risk assessments and perform ethnographic analysis.Plan and support the execution of design validation studies.Author and/or provide oversight to human factors documents for device and combination product design history files.Interacting with external human factors vendors and senior leaders with regards to human factors strategy and implementation.Assist in platform device and packaging design and development identifying ways improve platform efficiency.Support the team by managing action plans and project plans to deliver short-, mid- and long-term development goals.Effectively communicate your work to the wider development team and stakeholders.Manage external vendors or partners as required to advance project milestones.Provide mentorship to junior scientists/engineers to develop appropriate internal capability.Maintain accountability for project success and results delivery.Support authoring and review of regulatory submissions and written responses.Here's What You'll Bring to the Table:BS (8+ years), MS (5+ years) or PhD in Human Factors/Systems/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry or related scientific disciplines with industry experience in small and/or large molecule combination drug product development.Exceptional laboratory skills and hands-on experience with aseptic liquid filling and handling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems.Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.Ability to perform data analysis using advanced statistical, including design of experiments (DoE) approaches leveraging statistical analysis softwareExperience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.Knowledge of GMP and GLP complianceModerna 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 parents401k 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 ModernaSince 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 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. We're 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 ****** . (EEO/AAP Employer) -
