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Full-Time

Principal Scientist

Bioanalytical and Molecular Assay

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Expert

Norwood, MA, USA

70% in-office structure.

Category
Bioinformatics
Biology Lab & Research
Biology & Biotech
Required Skills
Data Analysis
Google Cloud Platform
Requirements
  • 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.
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 Moderna’s 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.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a molecule that provides instructions for cells to produce proteins essential for various biological functions. Their approach involves creating a new class of medicines that leverage mRNA to potentially enhance the discovery, development, and manufacturing of drugs. Unlike traditional methods, which often rely on proteins or other biological materials, Moderna's use of mRNA allows for a more versatile and efficient way to create treatments. The company's goal is to improve patient outcomes by harnessing the power of mRNA to address a wide range of health issues.

Company Stage

Grant

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

3%

1 year growth

8%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Moderna's expansion into combination vaccines and autoimmune therapies showcases its potential for diversified revenue streams and market leadership.
  • The company's continuous innovation and FDA approvals for updated COVID-19 vaccines highlight its resilience and adaptability in a rapidly changing market.
  • Moderna's educational initiatives, like the free mRNA course, position it as a thought leader and advocate for mRNA technology.

What critics are saying

  • The collapse in demand for COVID-19 vaccines could significantly impact Moderna's revenue and growth prospects.
  • Ongoing class action lawsuits alleging securities fraud could damage Moderna's reputation and financial stability.

What makes Moderna unique

  • Moderna is pioneering the use of mRNA technology to create a new class of medicines, setting it apart from traditional pharmaceutical companies.
  • The company's focus on mRNA as the 'software of life' allows for rapid development and manufacturing of vaccines and therapies, unlike conventional methods.
  • Moderna's ability to secure regulatory approvals for mRNA vaccines beyond COVID-19, such as for RSV, demonstrates its leadership in mRNA technology.