Full-Time

Principal Engineer

Drug Product, Global Engineering

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Norwood, MA, USA

Role is based in Norwood, MA with potential travel up to 30% for global manufacturing expansion.

Category
Embedded Engineering
Software Engineering
Required Skills
PowerPoint/Keynote/Slides
Requirements
  • Ph.D. in Chemical Engineering, Mechanical, or a related field with 8+ years of relevant experience, or
  • M.S. with 10+ years of relevant experience, or
  • B.S. with 12+ years of relevant experience.
  • Extensive experience in aseptic processing and sterile manufacturing.
  • Proven track record of successful commissioning, qualification, validation, and commercialization of aseptic processes.
  • Strong knowledge of GMP, ICH guidelines, and regulatory requirements for aseptic operations.
  • Experience with various aseptic techniques and equipment (e.g., isolators, cleanrooms, sterilization methods).
  • Excellent problem-solving and analytical skills.
  • Strong project management and organizational abilities.
  • Effective communication and interpersonal skills.
  • Ability to work collaboratively in a cross-functional team environment.
  • Proficiency in using aseptic process development and validation tools.
  • Experience in large capital/expansion programs with direct design responsibility.
  • Expected to be able to present own work to peers and cross-functional managers and influence decisions.
  • Must be able use technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions for complex problems.
  • Proficient with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.
  • Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from supervisor.
  • Ability to represent Moderna’s mindsets, objectives, and policies in a professional and responsible manner.
Responsibilities
  • Lead the design and development of aseptic manufacturing processes for Drug Product facilities.
  • Lead Front End Planning (FEP) activities for the fill finish equipment scope on capital projects and programs.
  • Lead equipment vendor selection and assessments.
  • Develop user requirements, design specifications, process parameters, and FMEA assessments.
  • Develop and maintain contamination control strategies to prevent microbial contamination.
  • Ensure all aseptic operations adhere to Good Manufacturing Practices (GMP) and other relevant guidelines.
  • Lead strategies for aseptic process commissioning, qualification and support Media Fills and process validation, support protocols development in compliance with regulatory requirements (e.g., FDA, EMA).
  • Prepare and review technical documentation, including validation reports, standard operating procedures (SOPs), and regulatory submissions.
  • Serve as a Subject Matter Expert and work closely with Manufacturing and other functional groups to implement and scale up aseptic processes.
  • Provide technical leadership and guidance to junior engineers and others in equipment design, problem-solving efforts and troubleshoot aseptic process issues.
  • Identify new technologies in aseptic processing and sterile manufacturing technologies.
  • Drive results by owning deliverables and assuring on-time milestones completion in capital projects.
  • Mentor and train team members on best practices in aseptic operations.

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 chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to harness the power of mRNA to improve patient outcomes and create effective treatments for a range of diseases.

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

  • mRNA technology is expanding into personalized cancer vaccines, revolutionizing treatment.
  • Recent advancements in lipid nanoparticle delivery enhance mRNA vaccine efficacy.
  • Global mRNA vaccine market projected to grow significantly, boosting Moderna's prospects.

What critics are saying

  • Potential exclusion from Nasdaq 100 could impact investor perception and liquidity.
  • Bypassing safety steps in Australia may raise regulatory scrutiny.
  • Geopolitical tensions in China pose operational and financial risks for Moderna.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for a new class of medicines.
  • The company has developed one of the earliest and most effective COVID-19 vaccines.
  • Moderna's mRNA platform enables rapid development of vaccines for various diseases.

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