Associate Director, Upstream Process

Merck Sharp & Dohme Corp

Hyderabad, India
Hybrid
Biologics drug substance manufacturing
Technical transfers to/from external partners
Continuous commercial manufacturing support
Support a technical team interfacing between Merck Sharp & Dohme Corp and External Partners in Biologics Drug substance manufacturing

Job Summary

  • Support a technical team interfacing between Merck Sharp & Dohme Corp and External Partners in Biologics Drug substance manufacturing.
  • Provide global technical operations support for continuous commercial manufacturing at an External Partner, including process validation and issue resolution.
  • Collaborate with External Partners on technical transfers, process performance analysis, change management, and continuous improvement initiatives.

Matching Summary

Support a technical team interfacing between Merck Sharp & Dohme Corp and External Partners in Biologics Drug substance manufacturing.

Skills & Requirements

Must-have

  • Biologics Drug substance manufacturing
  • Technical transfers to/from External Partners
  • Continuous commercial manufacturing support
  • Process validation completion
  • Troubleshoot manufacturing issues
  • Regulatory filing support

Nice-to-have

  • High Performance Organizational tools
  • Manufacturing digitalization understanding
  • Computer system validation requirements
  • Cross-Cultural Awareness
  • Cultural Awareness

Key Requirements

  • Minimum 12 years experience
  • Bachelors or Masters degree
  • Highly regulated certified manufacturing plants experience
  • Cell banking experience
  • Cell Culture manufacturing process experience
  • Technical transfer experience
  • Process validation experience

Work Rights

Not specified

Tailored Resume

Cover Letter