Biologics Dp Leader

GSK

Multiple Locations
Biologics drug product lifecycle management
Technology transfer leadership
Process validation and robustness
Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product, including Technical Risk Assessment and Process Validation

Job Summary

  • Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product, including Technical Risk Assessment and Process Validation.
  • Leads the technology transfer from R&D and between manufacturing sites, internally and externally, while ensuring QbD principles are applied.
  • Provides technical leadership and establishes key relationships with operational teams on manufacturing sites and with R&D.

Matching Summary

Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product, including Technical Risk Assessment and Process Validation.

Skills & Requirements

Must-have

  • Biologics Drug Product Lifecycle Management
  • Technology Transfer Leadership
  • Process Validation and Robustness
  • Cross-functional Improvement Projects
  • Regulatory Filing Support

Nice-to-have

  • Problem Solving and Creative Thinking
  • Influencing and Driving Change
  • Knowledge Management and Sharing
  • Emerging Regulatory Strategies

Key Requirements

  • BS with 10 years pharmaceutical experience
  • MS with 8 years pharmaceutical experience
  • PhD with 4 years pharmaceutical experience

Work Rights

Not specified

Tailored Resume

Cover Letter