Planning, coordination and documentation of research and development work performed in the department;
Coordination and management of biological tests for original and bio-similar substances and small molecules;
Leading the staff of the department to deliver high quality results, meeting the timelines;
Introduction, adaptation of quality control tests using bioassays (in vivo, mammalian cell based, ELISA based tests);
Professional management of bio-analysis of preclinical and clinical samples (biotechnological and bio-similar products) using ligand binding assays;
Professional management of detection of anti-drug antibodies from clinical and preclinical samples;
Coordination of test method development and validation;
Maintaining the GMP and GMP compliance of the department;
Preparation of SOPs, validation of instruments, preparation of protocols and reports;
Coordination of tasks related to the operation of the animal house;
Professional support and training of the employees;
Planning and improving the long-term capabilities of the department as well as communication with international R&D units of the company and with external partners;
Active participation on inspections of the department, communication with the inspectors.
Követelmények
MSc degree in Biology, Biological Engineering, Immunology or similar field; PhD is a plus;
Fluent English knowledge;
Experience in ELISA based and/or mammalian cell based methods, bioassays; experience with work related to experimental animals is preferred;
Experience in a manager role;
Experience of working in GLP and GMP environments and/or in the pharmaceutical industry is a huge advantage;
User level IT skills;
Precise work, analytical thinking, problem solving capabilities and proactivity is a must.
