Clinical Research / Marketing Authorisation
Clinical Research tests new drugs in clinical trials, before application can be made for marketing authorisation for these drugs with the competent authority.
Continuous monitoring of product tolerability is ensured by Drug Safety. Staff in this department works closely with research institutes, testing centres and scientific cooperation partners.
They are in contact with doctors, authorities and ethics committees and also share their knowledge in conferences and presentations.
All data and studies are assembled and evaluated by the Data Management, Biostatistics and Quality Management department.
The manufacture and sale of drugs takes place in the very sensitive environment of health and medicine. Contribute to Quality Management, which ensures ongoing quality control and monitoring of production processes, to guarantee and further develop our consistently high quality.
Drugs are manufactured using cutting-edge technology in cleanroom and GMP-compliant conditions by our demanding Production department. Our employees are motivated not least by the knowledge that the products they make can save lives. The work environment is one of teamwork and trust.
From building engineering to manufacturing facilities – Engineering ensures that work processes run smoothly, whatever the location. Therefore we are looking for experts who can show that they do meticulous work.
Marketing and Sales
Even the best product needs highly qualified employees in Marketing and Sales. At Biotest you can apply your skills to diverse and challenging tasks in the global markets.
Central Project Management
Together with the rest of the staff, our employees in the central services of Purchasing, Logistics, Controlling, Finance, IT, HR and Legal contribute to shaping our growth. They adapt existing processes to the changing needs of the company and its employees, and help it to develop further. This is where skill, commitment, team spirit and communication come together.
Professional, varied, exciting: An apprenticeship at Biotest, whether in a technical, scientific or business field, gives you a solid foundation for your professional future. You will not find a run-of-the-mill programme, but a well-grounded apprenticeship that builds your skills and promotes your interests, as well as bringing the fascinating pharmaceutical industry to life.
Whether for internships, thesis work, postdoctoral or trainee programmes, in all cases: You will not find a run-of-the-mill programme, but diverse tasks that strengthen your individual skills, while also bringing the fascinating pharmaceutical industry to life.
Corporate Regulatory Affairs
The core function of the CRA unit is the regulatory approval of Biotest products as well as all activities that serve to maintain and extend these product approvals.
Development of plasma proteins
The Plasma Protein Development unit is responsible for the development of production processes for new products at Biotest. In addition, the characterisation and validation of production processes on a laboratory scale, the production of test goods for clinical investigations for phase I, II, III studies and the support of ongoing Biotest production in troubleshooting are the focus of the divisions activities.
Corporate Medical Affairs
Corporate Medical Affairs (Medical Science Division) is focused on generating and communicating new insights and knowledge relating to medicinal products on the market. In doing so, the division maintains a close relationship with healthcare professionals and other Biotest units such as Marketing and Sales, Drug Safety, Clinical Research and Drug Regulatory Affairs.
Preclinical Research conducts research on new and known active substances, examines the quality of processes and products and conducts studies on pharmacology, pharmacokinetics and toxicology. For this purpose, the department works closely with other research and development departments, scientific partners, and research institutes.
The Pathogen Safety unit is responsible for virus validation studies of production processes. Production processes are simulated on a laboratory scale and tested for their removal capacity for model viruses or prions. We cooperate closely with other departments to optimise the yield, purity and manufacturing costs of the products, as well as to ensure virus and prion protection. After successful development and validation, the data is collated for the purpose of conducting clinical trials or for the submission of regulatory approval.
Corporate Clinical Research & Development
The core business of CCR&D is strategic clinical planning, design development, and the preparation, conducting and evaluation of clinical trials. The studies mainly evaluate the effectiveness, tolerance and safety of new drugs and those already approved. In this way, clinical research also supports the introduction of new medicines and types of therapy to the market in order to ensure better patient care.
Analytical Development and Validation
The ADV unit is responsible for method development / optimisation and method validation of GMP-relevant clearance, stability and in-process control methods for quality control. In this way on the one hand methods from the research areas are adapted to GMP requirements and on the other hand existing tests are adapted to new products. After successful development and validation, the methods are transferred to quality control for routine testing.