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Full-Time

Associate Director

Global Regulatory Science CMC, Infectious Diseases

Confirmed live in the last 24 hours

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Healthcare
Biotechnology

Senior

Norwood, MA, USA

The Associate Director will be based at the Norwood, MA site.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
  • 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
  • 5+ years of experience in Biologics focused Regulatory CMC
  • Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions
  • Knowledge of current CMC regulations outside of the US, as well, is preferred
  • Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM)
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones
  • Ability to work independently
  • Exceptional written and oral communication
Responsibilities
  • Develop/implement effective regulatory CMC strategies for US submissions (ex. CMC PAS, CBE-30) and identify regulatory risks
  • Provide regulatory CMC advice to manufacturing and quality teams
  • Review documents for submission-readiness, to ensure that all submissions conform to US regulatory requirements
  • Lead regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
  • Assess change controls
  • Support development of regulatory processes and procedures
  • Support the creation and maintenance of CMC submission tools and templates
  • Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

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.