Site Sterility Lead, Associate Director - Dundalk

39med

Dundalk, Ireland
Hybrid
Bachelor's degree in microbiology
10+ years biopharma experience
Eu gmp annex 1 expertise
39med is seeking an Associate Director, Site Sterility Lead for their Dundalk facility, focusing on sterile vaccine production. The role involves driving aseptic standards, mentoring personnel, and ensuring compliance with regulatory requirements

Job Summary

  • This role offers a high-impact opportunity to shape aseptic standards and mentor operations personnel within a dynamic, multi-product vaccine manufacturing environment.
  • The successful candidate will serve as the Subject Matter Expert for site sterility assurance, ensuring alignment with EU GMP Annex 1 (2023) and cGMP requirements.
  • You will act as the site owner of the Environmental Monitoring Program, leading microbial investigations and driving site inspection readiness for global audits.

Matching Summary

Match Score: 85

39med is seeking an Associate Director, Site Sterility Lead for their Dundalk facility, focusing on sterile vaccine production. The role involves driving aseptic standards, mentoring personnel, and ensuring compliance with regulatory requirements.

Skills & Requirements

Must-have

  • Bachelor's degree in microbiology
  • 10+ years biopharma experience
  • EU GMP Annex 1 expertise
  • Environmental monitoring program ownership
  • Root cause analysis skills
  • Contamination control strategy design

Nice-to-have

  • Strong written communication abilities
  • Mentoring operations personnel
  • Driving continuous improvement
  • Global audit inspection readiness
  • Microbiology best practices sharing

Key Requirements

  • Bachelor's degree in microbiology or relevant discipline
  • 10+ years of experience in Biopharma/Pharma Industry
  • Expertise in Eudralex Annex 1 requirements
  • Proven experience in root cause analysis and risk management

Work Rights

Not specified

Tailored Resume

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