Senior Scientist, Bioanalytical and Molecular Testing

2 weeks ago


Norwood, Massachusetts, United States Moderna Full time

Overview:

Moderna is in search of a seasoned Senior Scientist to become a vital member of our Bioanalytical and Molecular Testing division. This position is crucial for supporting regulated non-clinical evaluations and clinical investigations, with a specific emphasis on the bioanalytical analysis of cellular therapies and the assessment of humoral and cellular immune responses to mRNA-LNP therapeutics.

Key Responsibilities:

- Formulate and implement phase-appropriate clinical bioanalytical approaches, focusing on the quantification and characterization of engineered cellular therapies and immunogenicity assessments (ADA, APA, nAb, ELISpot) for mRNA-LNP therapeutics. This encompasses method development, validation, and sample analysis adhering to GLP/GcLP standards.

- Direct a team to guarantee timely assay development, regulatory-compliant qualification or validation of assays, and resolution of any issues arising from internal or external CRO partners.

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

- Assist in and promote method development to support Moderna's portfolio, including the procurement and qualification of analytical equipment and the preparation and upkeep of standard operating procedures (SOPs).

- Possess hands-on experience with various Laboratory Information Management Systems such as Thermo Watson, LabVantage, and ELN. Familiarity with AI applications in regulated bioanalysis is preferred.

- Exhibit comprehensive knowledge of governmental guidelines and internal protocols regarding clinical trial execution, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs, and relevant White Papers for clinical bioanalysis to ensure practices align with regulatory expectations.

Qualifications:

- Ph.D. in Cell Biology, Immuno-oncology, Immunology, Cancer Biology, or related disciplines with a minimum of 9+ years of experience in the biotech/pharmaceutical sector. A B.S./M.S. with substantial bioanalytical expertise will also be considered.

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

- Ability to effectively convey scientific concepts, program objectives, and data analysis within a collaborative environment.

- Strong comprehension of GLP requirements and current industry trends and regulatory expectations related to bioanalytical science. Extensive knowledge of regulatory guidelines such as BMV, M10, and similar.

About Moderna:

Since our inception, we have aimed to establish the foremost mRNA technology platform, creating the infrastructure to revolutionize how medicines are developed and delivered, alongside a world-class team. We believe in empowering our personnel to transform medicine and make a significant impact on the world.

By embodying our mission, values, and mindsets daily, our workforce drives our scientific advancements and organizational culture. Together, we are fostering a culture of inclusion and building an organization that genuinely cares for our patients, employees, the environment, and our communities.

Moderna is committed to providing a smoke-free, alcohol-free, and drug-free work environment, ensuring that every employee can thrive.

Equal Opportunity:

Moderna is proud to be an equal opportunity workplace and an affirmative action employer, dedicated to equal employment opportunity and non-discrimination for all employees and qualified applicants.



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