Msat Formulation & Filling Lead

Roche

Shanghai, , China
Aseptic formulation and filling operations
Cgmp compliance and quality standards
Technical transfer and process validation
Roche fosters a culture of personal expression, open dialogue, and genuine connections, valuing and respecting each individual to thrive personally and professionally

Job Summary

  • Roche fosters a culture of personal expression, open dialogue, and genuine connections, valuing and respecting each individual to thrive personally and professionally.
  • The role leads excellence in aseptic formulation and fill-and-finish operations at a greenfield biopharmaceutical manufacturing facility, ensuring integration of cutting-edge technologies and compliance with cGMP/SHE standards.
  • This highly collaborative position requires driving technical innovation, operational readiness, and global knowledge-sharing to improve efficiency, quality, and scalability of aseptic manufacturing processes.

Matching Summary

Roche fosters a culture of personal expression, open dialogue, and genuine connections, valuing and respecting each individual to thrive personally and professionally.

Skills & Requirements

Must-have

  • aseptic formulation and filling operations
  • cGMP compliance and quality standards
  • technical transfer and process validation
  • formulation optimization and container integrity
  • operational readiness and ramp-up
  • risk management in aseptic processes
  • cross-functional collaboration

Nice-to-have

  • leadership and mentoring skills
  • lean manufacturing principles
  • innovation and continuous improvement
  • global manufacturing strategy alignment
  • digital and automated solutions
  • experience with new facility startup
  • vendor collaboration and external CMO support

Key Requirements

  • Bachelor’s degree in Pharmaceutical or Biological sciences preferred
  • Minimum 5 years formulation and/or aseptic filling experience
  • At least 8 years MSAT/technical or operational experience in injection pharmaceutical industry
  • Experience in aseptic filling facility design, commissioning, and qualification
  • Comprehensive knowledge of cGMP and pharmaceutical regulations
  • Fluent English communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter