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Full-Time

Scientist – Immunogenicity

Bioanalytical and Molecular Assays

Posted on 9/12/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Mid, Senior

Oxford, UK

70% in-office structure.

Category
Bioinformatics
Computational Biology
Biology Lab & Research
Biology & Biotech
Required Skills
Data Analysis
Google Cloud Platform
Requirements
  • A Ph.D. with at least 3+ years or BSc. with 5+ years of demonstrated hands-on experience development and validation of bioanalytical methods in infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields.
  • Knowledge of GLP and GCP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.
  • Expert knowledge of various assay platforms such as ECL, Cell culture, immunoassays, bDNA and other methodologies for clinical assays is preferred.
  • Hands-on experience in cell culture assays is an advantage.
  • Experience with RNA, biologics and cell therapy preferred.
  • Expert knowledge of Watson LIMS.
  • Willingness to learn new concepts and challenge boundaries.
  • Attention to detail and ability to handle multiple projects in a fast-paced environment.
  • Experience using various LIMS systems is preferred.
  • Knowledge of FDA and global data standards required.
  • Ability to effectively communicate scientific concepts, program objectives, and data analysis within a matrix environment.
Responsibilities
  • Design and execute phase-appropriate bioanalytical strategies, including immunogenicity (anti-drug antibodies and neutralizing antibody assays) and quantitation of therapeutic proteins (PK/PD assay) method development.
  • Ensure assays are developed on time, meet regulatory standards, and troubleshoot any issues internally or with external CRO partners.
  • Develop various assays using ELISA, MSD, cell culture, immunoblotting, and other relevant technologies.
  • Establish internal and external ASO bioanalytical capabilities and facilitate method development to support Moderna’s portfolio.
  • Manage analytical equipment procurement/qualifications, prepare and maintain SOPs, and oversee critical reagents.
  • Collaborate with preclinical and clinical operations to define sample journeys and develop laboratory manuals.
  • Set up analytical LIMS profiles for sample analysis and assay validations.

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.
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