Drug Product Validation Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeValidation Full time $140,000 - $170,000
Principal Research Associate

You will be responsible for establishing drug product activities at our site.

Key Responsibilities:

  • Lead formulation, fill/finish, visual inspection, packaging, and related process validation and tech transfer activities.
  • Ensure manufacturing alignment with mRNA/LNP platform standards, author and review cGMP documentation.
  • Perform risk assessments, generate SOPs, and establish training programs.
  • Monitor key performance indicators to identify and improve inefficiencies.
  • Support operational metrics.
  • Investigate complex manufacturing issues with cross-functional teams.
  • Act as technical expert for audits and inspections.
  • Collaborate with global sites on data sharing and best practices.
  • Integrate Lean and Six Sigma principles for continuous improvement.

Requirements:

  • Maintain deep expertise in quality systems, cGMP, and industry standards.
  • Perform additional duties as assigned, including exploring opportunities for integration of Generative AI tools to streamline validation and investigation processes.

About the Role:

This role offers a challenging opportunity to work as a technical specialist ensuring robust validation practices, technology transfers, continued process verifications, investigations, and change management in support of a new drug product manufacturing line.

The successful candidate will have strong leadership skills, excellent communication abilities, and the ability to collaborate effectively with cross-functional teams.

Our company is committed to delivering high-quality products to the market, and this role plays a critical part in achieving that goal.

What We Offer:

  • A competitive salary and benefits package.
  • The opportunity to work with a pioneering biotech company.
  • A dynamic and supportive team environment.
  • Continuous learning and development opportunities.

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