Principal Scientist, Bioanalytical and Molecular Assay at Moderna, Inc.

Overview:

Moderna is seeking an experienced Principal Scientist to join our Bioanalytical and Molecular Assays team. This role involves supporting regulated non-clinical studies and clinical trials, specifically focusing on the bioanalytical assessment of cell therapies and the characterization of humoral and cellular immunogenicity of mRNA-LNP therapeutics.

Key Responsibilities:

• Design and execute phase-appropriate clinical bioanalytical strategies, including quantitation and characterization of engineered cell therapies and immunogenicity evaluations (ADA, APA, nAb, ELISpot) of mRNA-LNP therapeutics. This includes method development, validation, and sample testing under GLP/GcLP regulations.

• Lead a team to ensure timely assay development, regulatory-compliant qualification or validation of assays, and troubleshooting of any internal or external CRO partner issues.

• Develop cell-based nAb assays, cell therapy PD assays (Flow Cytometry), immune cell activation assays (ELISpot), APA, and/or PD assays using technologies such as ELISA, MSD, Gyros, multiplex LBAs, and Luminex-based protein assays.

• Support and facilitate method development to support Modernas portfolio, including analytical equipment procurement/qualifications and preparation and maintenance of SOPs.

• Hands on knowledge of various Laboratory Information Management Systems such as Thermo Watson, LabVantage, ELN etc. Knowledge of AI application in regulated bioanalysis is preferred.

• Deep knowledge of government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.

Qualifications:

• Ph.D. in Cell Biology, Immuno-oncology, Immunology, Cancer Biology, or related fields with a minimum of 9+ years of biotech/pharmaceutical industry experience. A B.S./M.S. with extensive bioanalytical experience will also be considered.

• Preferred experience with RNA, biologics, and cell therapy. Expert knowledge of cell-based assays, including flow cytometry and ELISpot or similar methodologies for pre-clinical and clinical assays, is required.

• Ability to effectively communicate scientific concepts, program objectives, and data analysis within a matrix environment.

• Strong understanding of GLP requirements and current industry trends and regulatory expectations associated with bioanalytical science. Deep knowledge of regulatory guidances such as BMV, M10 and similar.

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.

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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