Drug Product Manufacturing Specialist (m/w/d)

Role Description: 

The Drug Product Manufacturing Specialist ensures safe, timely, and compliant execution of manufacturing activities under cGMP guidelines. 

Key responsibilities include:

• Performing batch execution, evaluating test results, and troubleshooting equipment.

• Providing technical and procedural support to the manufacturing team.

• Ensuring each batch is manufactured safely, on time, and meets quality requirements.

• Preparing, executing, and reviewing production documentation, including batch records and GMP documents.

• Supporting process investigations, process changes, and CAPA implementation.

• Conducting operator training and supporting onboarding of new team members.

• Operating, setting up, and cleaning production equipment for liquid and freeze-dried drug forms (e.g., compounding, parts washing, autoclaving, filter integrity testing, visual inspection).

Profile:

• Experience: 2-4 years in a GMP environment, preferably in sterile drug product manufacturing.

• Languages: Fluent in English or German (both preferred).

• Skills:

  • Familiarity with GMP requirements, quality procedures, and SOPs.

  • Strong team orientation and communication skills.

  • Structured, organized, and focused work approach.

  • High motivation and dynamic drive.

  • IT skills; knowledge of SAP and MES is beneficial.

• Flexibility: Willingness to work flexible hours.