Biotechnology Quality Control Lead

1 week ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time

About the Role:

We are seeking a seasoned Quality Control Lead to join our Microbiology Technical Operations team at AGC Biologics.

Job Summary:

This is an excellent opportunity for a motivated and experienced professional to lead our QC Microbiology method transfers, verification, new product onboarding, risk assessments, and other technical activities.

Main Responsibilities:

  1. Lead a Team of Professionals: Manage a team of Microbiology Technical Operations professionals, providing guidance, training, and development opportunities to ensure high-quality work and team growth.
  2. QC Microbiology Method Verification: Oversee the verification of QC Microbiology methods, ensuring compliance with regulatory standards and company procedures.
  3. New Product Onboarding: Coordinate and lead the onboarding process for new products, including risk assessments and quality control measures.
  4. Contamination Control Strategies: Support and lead Contamination Control Strategies for our CO sites, ensuring adherence to cGMP regulations.
  5. Technical Expertise: Act as a Subject Matter Expert for technical Microbiology-related questions, providing guidance and support to internal and external teams.
  6. Regulatory Compliance: Ensure that all QC Microbiology operations conform to applicable regulatory standards and company policies.
  7. Project Management: Prioritize and assign tasks, manage daily operations, and coordinate with other teams to meet organizational goals.

Requirements:

Qualifications: Bachelor's degree in a relevant field (e.g., Microbiology, Biology, Chemistry) or equivalent experience. 8+ years of industry experience, or Master's degree with 6+ years of industry experience.

Preferred Qualifications: Experience with facility contamination control, Environmental and Utility Monitoring, Microbiology QC method verification and validation, subject matter expertise in Microbiology-related deviations and aseptic/sterility assurance process improvement activities.

Salary Range: $94,000 - $129,250 per year.

About AGC Biologics:

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO). We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA, messenger RNA, viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide.



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