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

Biotechnology
Healthcare

Expert

Norwood, MA, USA

70% in-office presence required.

Category
Bioinformatics
Computational Biology
Biology Lab & Research
Biology & Biotech
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 crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
Simplify Jobs

Simplify's Take

What believers are saying

  • Moderna's AI-driven drug discovery accelerates novel mRNA-based therapeutics identification.
  • Expansion in Asia enhances global supply chain and reduces production costs.
  • mRNA technology is gaining traction for non-infectious disease vaccines, like cancer.

What critics are saying

  • Potential Nasdaq 100 removal could impact stock visibility and investor interest.
  • Bypassing safety steps in Australia may raise regulatory and public scrutiny concerns.
  • Hong Kong's reluctance to receive Covid-19 jab affects market penetration and sales.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company focuses on mRNA's potential to transform drug discovery and manufacturing.
  • Moderna's mRNA platform enables rapid development of vaccines and therapeutics.

Help us improve and share your feedback! Did you find this helpful?