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AGC Biologics

End-to-end biopharma CDMO for gene therapies

Manufacturing Compliance Support

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeHeidelberg, GermanyIn-person

About the Job

Requirements

  • Completed vocational training in a scientific, technical, pharmaceutical, or food-technology occupation, such as biology laboratory technician, chemistry laboratory technician, pharmaceutical technician, or pharmaceutical technical assistant, or comparable training.
  • Initial practical exposure to pharmaceutical, biotechnological, or other regulated production.
  • A basic understanding of good manufacturing practice, quality-related documentation, and standardized workflows is advantageous.
  • Strong organizational ability and a careful, structured working style.
  • Willingness to approach colleagues, obtain information, and consistently follow up on issues.
  • Strong sense of responsibility, reliability, and attention to completeness and accuracy.
  • Interest in professional development and in learning the production and compliance processes of a biopharmaceutical company.
  • Good spoken and written German and English.

Responsibilities

  • Prepare production documents for use in manufacturing areas, including PWR documentation and labels, according to team-lead instructions.
  • Print and assemble Master Production Records, including FRMs, SPPs, dispensing FRMs, and associated attachments.
  • Check issued documents for completeness and correct assembly.
  • Create and maintain equipment calibration lists.
  • Process completed batch records and verify completeness of both pages and content in accordance with good documentation practice.
  • Follow up on missing or incorrect documents, measurement data, and printouts, and document them in the correction tool.
  • Obtain PWR certificates from Quality Control.
  • Support simple training activities.
  • Coordinate student assistants, for example for scanning completed batch records.

Desired Qualifications

  • A basic understanding of good manufacturing practice, quality-related documentation, and standardized workflows is advantageous.

About the Company

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AGC Biologics

End-to-end biopharma CDMO for gene therapies

AGC Biologics is a global contract development and manufacturing organization (CDMO) that develops and manufactures biopharmaceuticals, including therapeutic proteins, plasmid DNA, viral vectors, and cell therapies. It offers end-to-end services from early development through commercial-scale manufacturing, with fast-track options for orphan drugs and rare diseases. The company runs cGMP-compliant facilities across the US, Europe, and Asia, recently expanding with a Longmont, Colorado site focused on cell and gene therapies. Its goal is to help biopharma partners bring new treatments to market efficiently and safely by providing integrated development and manufacturing, supported by its international footprint and project acceleration capabilities.

Company size
1,001-5,000
Company stage
Acquired
Total funding
$557.7M
Headquarters
Bothell, WA
Founded
2001

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