Head of Biological Control Department (Debrecen)

Head of Biological Control Department (Debrecen)
A hirdetés már lejárt!


Head of Biological Control Department

Feladatok

  • 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.

Amit kínálunk

  • Competitive salary and benefit package;
  • Dynamic and professional atmosphere;
  • Career development opportunities.

Munkavégzés helye

Debrecen

Debrecen

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