QC Microbiology Analyst

at  BSP Pharmaceuticals

DESCRIZIONE AZIENDA

BSP Pharmaceuticals S.p.A is a Contract Development and Manufacturing Organization (CDMO).The BSP campus hosts 2 segregated facilities to serve the clients with development from pre-clinical GLP to cGMP manufacturing for clinical and commercial supply of Cytotoxic and High Potent Oncology drugs and Non-Cytotoxic, innovative compounds for Immunotherapy and other therapeutics applications.Facilities designed to handle small and large molecules as ADCs (conjugation and fill finish), Peptides, Proteins, Oligonucleotides and Nano Medicines.BSP is technologically developed to meet the needs of innovators, with its High Containment Facility designed to offer a full range of integrated services aimed to support the entire life cycle of a product, from the formulation and process development/optimization, through scale up/scale down studies

POSIZIONE

We are currently looking for a QC Microbiology Analyst

Responsibilities:

• Use and check the analysis equipment in the laboratory
• Execute the biological and microbiological analysis of raw materials and non-sterile finished products in accordance with current analytical methods, reporting any anomalies to the superior in a timely manner
• Execute sterility tests within the isolator system and its care and maintenance according to the analytical methods in force
• Execute all microbiological validation activities from a managerial, documentary and operational point of view
• issuing and reviewing laboratory documentation
• Carries out the visual inspection of containers from simulated fillings (Media Fill) and their disposal
• Being the responsable for the preparation and sterilisation of culture media and their control in accordance with current SOPs
• Participate in the evaluation of materials to be purchased for analytical activities and their documentation
• Take care of instruments, materials and the work environment, reporting any anomalies to the superior in a timely manner
• He/she is responsible for the disposal of waste and its possible inactivation
• EHS obligations and responsibilities: refer to Art. 20 of Legislative Decree 81/08 as amended - Workers’ obligations

• Use and check the analysis equipment in the laboratory
• Execute the biological and microbiological analysis of raw materials and non-sterile finished products in accordance with current analytical methods, reporting any anomalies to the superior in a timely manner
• Execute sterility tests within the isolator system and its care and maintenance according to the analytical methods in force
• Execute all microbiological validation activities from a managerial, documentary and operational point of view
• issuing and reviewing laboratory documentation
• Carries out the visual inspection of containers from simulated fillings (Media Fill) and their disposal
• Being the responsable for the preparation and sterilisation of culture media and their control in accordance with current SOPs
• Participate in the evaluation of materials to be purchased for analytical activities and their documentation
• Take care of instruments, materials and the work environment, reporting any anomalies to the superior in a timely manner
• He/she is responsible for the disposal of waste and its possible inactivation
• EHS obligations and responsibilities: refer to Art. 20 of Legislative Decree 81/08 as amended - Workers’ obligation