Lead Manufacturing Associate - Lyophilization

Alamar Biosciences

Fremont, US
On-site
7+ years pharmaceutical manufacturing experience
4+ years hands-on lyophilization expertise
Iso 13485 and cgmp compliance knowledge
The role serves as the subject matter expert to commission new lyophilizers and drive continuous improvements for processes and equipment

Job Summary

  • The role serves as the subject matter expert to commission new lyophilizers and drive continuous improvements for processes and equipment.
  • Candidates will be responsible for planning production activities, overseeing staff, and ensuring compliance with ISO 13485 and cGMP standards.
  • The position requires collaborating with Product Development to transfer new processes into routine manufacturing while generating risk assessments.

Matching Summary

The role serves as the subject matter expert to commission new lyophilizers and drive continuous improvements for processes and equipment.

Skills & Requirements

Must-have

  • 7+ years pharmaceutical manufacturing experience
  • 4+ years hands-on lyophilization expertise
  • ISO 13485 and cGMP compliance knowledge
  • Production planning and execution skills
  • SOP and deviation report management

Nice-to-have

  • Process development and optimization experience
  • Mechanical aptitude for troubleshooting
  • Strong analytical data interpretation skills
  • Collaborative cross-functional teamwork
  • Fast-paced dynamic environment adaptability

Key Requirements

  • Bachelor's degree in biological sciences or chemical engineering
  • Minimum 7 years total manufacturing experience
  • Minimum 4 years specific lyophilization experience
  • Knowledge of Good Manufacturing Practices (GMP)
  • Experience with formulation and scale-up

Work Rights

Not specified

Tailored Resume

Cover Letter