Biological Properties Analytics Senior Specialist

In this role you will focus on analytical methods related to active substances and biological products in registration, preclinical studies or implementation (pilot plant scale) phases. You will be responsible for development, qualification, validation and transfer of completely new analytical methods, or modification of existing ones.

• Independent reviews of technical literature in order to select appropriate analytical control methods for new substances and biotech drug forms
• Conducting independent research related to development of new and modification of existing analytical methods for the purpose of control of active substances and biotechnological medicinal products
• Performing independent tests of analytical control and evaluating of quality of substances and drug form during development phase and in pilot plant scale if required
• Analyzing and interpreting results of research without supervision
• Keeping records of carried out research and reporting results of conducted analyses in accordance with existing SOPs – taking care of data integrity
• Preparing analytical documentation required for the purpose of registration and implementation of new biotechnological processes (justification of specifications and test methods, compilation of results, protocols and reports etc.)
• Developing of SOPs and instructions as well as conducting training on them
• Supervising work of technicians, junior specialists and specialists
• Supervision of analytical laboratory in reference to past and upcoming inspections and requirements (internal and external)
• Evaluation of external companies’ documentation (analytical method development, qualification and transfer, samples analysis etc.)
• Participation in qualification of laboratory equipment
• Maintaining laboratory equipment in "ready to use" state in accordance with internal instructions and procedures
• Workplace organization and related control of usage and demands for materials, substances and reagents used during research
• Strict compliance with safety rules

• 5 years of experience in laboratory work (R&D or quality control laboratory), ideally in pharmaceutical industry
• University degree (Chemistry, Biochemistry, Biotechnology, Molecular Biology, Pharmacy. Medicine or similar), PhD would be an advantage
• Working knowledge of analytical techniques concerning therapeutic proteins, such as: electrophoretic techniques, blotting, PCR, ELISA, SPR, cell-based assays and associated cell cultures
• Working knowledge of software dedicated to data evaluation, i.e. Gen5, PLA, JMP, GraphPad Prism etc.
• Fundamental knowledge on regulatory guidelines and expectations, i.e. FDA, EMA, ICH, USP, Ph. Eur.
• Working knowledge of GDevP and/or cGMP and/or GLP
• Very good command of English (written and spoken)
• Working knowledge of MS Office
• Good organizational and teamwork skills
• Problem solving skills