Process Engineering Lead - Formulation, Filling, Inspection (cvrm)

Genentech

Holly Springs, North Carolina, US
Base: $114,400 - $256,800 depending on experience;...
Fully remote
Drug product manufacturing expertise
Process design and qualification
Project management and startup leadership
Pharma Technical Manufacturing manages all aspects of drug product manufacturing and supply to deliver Roche’s therapies worldwide

Job Summary

  • Pharma Technical Manufacturing manages all aspects of drug product manufacturing and supply to deliver Roche’s therapies worldwide.
  • The Process Engineering Lead will provide scientific and technical leadership for a new large volume manufacturing site focusing on compounding, filling, and inspection operations.
  • The role involves partnering with multiple departments, driving project and operational excellence, and fostering a positive safety culture.

Matching Summary

Pharma Technical Manufacturing manages all aspects of drug product manufacturing and supply to deliver Roche’s therapies worldwide.

Salary

Base: $114,400 - $256,800 depending on experience; Bonus/Equity: Discretionary annual bonus available; Benefits: Relocation benefits provided

Skills & Requirements

Must-have

  • Drug product manufacturing expertise
  • Process design and qualification
  • Project management and startup leadership
  • cGMP and regulatory compliance
  • Collaboration with cross-functional teams
  • Onsite and remote work flexibility
  • Safety culture and environmental health integration

Nice-to-have

  • Data science and smart factory concepts
  • Technology transfer and process validation
  • Coaching and training skills
  • Advanced problem solving and innovation
  • Experience with Health Authority inspections
  • Strong organizational and interpersonal skills

Key Requirements

  • Bachelor’s, Master’s, or Ph.D. in bio/chemical engineering or similar
  • 11+ years pharmaceutical industry experience
  • Expertise in drug product manufacturing unit operations
  • Experience with technology transfers and regulatory submissions
  • Up-to-date knowledge of cGMP and Health Authority regulations
  • Ability to travel up to 30% during project phase

Work Rights

Not specified

Tailored Resume

Cover Letter