- Lead design, execution, documentation, and presentation of relevant experimentation to support Drug Product teams in advancing formulation development, fill/finish process development, container development, process characterization, technology transfer, and regulatory authoring of our mRNA portfolio candidates.
- Design and execute detailed experiments using risk assessments, appropriate scale down models, QbD principles, and process characterization/modeling techniques to develop and troubleshoot specific unit operations.
- Author and review technical protocols, reports, product impact assessments, and regulatory sections as required in support of IND and marketing application submissions
- Enable development of container closure options for Moderna clinical and commercial products by establishing test protocols and procedures as well as partnerships with external partners as required.
- Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects
- Lead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables
- Support authoring and review of regulatory submissions
- BS (6+ years), MS (4+ years) or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry or related scientific disciplines with industry experience in small and/or large molecule parenteral drug product development.
- Exceptional laboratory skills and hands-on experience with aseptic liquid filling 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 software
- Experience working in matrix project teams with members from peer groups, CMC teams, R&D, CMOs and CROs.
- Knowledge of GMP and GLP compliance
- 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
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scientist, drug product development - Norwood, MA, United States - BioSpace
Description
Job DetailsThe Role:
Moderna 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, DPD is accountable for product image definition, formulation development, process development, characterization and scale up as well as technology transfer. The focus of this role will be supporting product development and program progression through planning and executing studies in the laboratory, and the authoring of protocols, reports and regulatory documentation.
Heres What Youll Do:
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 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 . (EEO/AAP Employer)
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