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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Bioconjugation Manufacturing Specialist

Bioprocess & BiomanufacturingPosted on Nov 12
Full-timeHalle, Germany

About the Job

Requirements

  • Completed vocational training as a chemical technician or pharmaceutical technician, or a comparable qualification in a pharmaceutical or biotechnological environment.
  • Experience in the chemical or pharmaceutical industry is advantageous.
  • Responsible and careful handling of high-value and/or toxic materials is required.
  • Good knowledge of Good Manufacturing Practice and Good Distribution Practice is required; experience in conjugation and purification processes is desirable.
  • A self-directed, disciplined, and responsible working style is required.
  • Very good spoken and written German and good spoken and written English are required.
  • Willingness to work in a shift system is required.

Responsibilities

  • Manufacture clinical products in compliance with Good Manufacturing Practice and safety standards, particularly carrying out bioconjugation and purification activities.
  • Participate in all process steps, including preparation, production, and post-production.
  • Operate complex production equipment, including diafiltration and chromatography systems and conjugation reactors.
  • Carry out process steps such as buffer preparation, solution filtration, and preparation of active substances in isolators.
  • Conduct in-process controls and routine measurements.
  • Actively participate in improvement initiatives while complying with 6S and hygiene standards.
  • Maintain batch and cleaning documentation and equipment logbooks.
  • Conduct test runs and perform equipment commissioning and qualification.

Desired Qualifications

  • Experience in the chemical or pharmaceutical industry.
  • Experience in conjugation and purification processes.

About the Company

Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable medicines. It supports pharmaceutical and biotechnology companies with formulation, process development, clinical and commercial manufacturing, filling, packaging and related technical services. Facilities and teams operate under regulated quality systems suited to complex parenteral products. Simtra is a business-to-business manufacturing partner rather than a consumer drug brand, helping sponsors move therapies from development into reliable supply through dedicated production expertise and capacity.

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