QC Microbiology Analyst

BSP Pharmaceuticals S.r.l.; Mostacciano; Ibrido; EUR 33.000 - 38.000; Tempo pieno

Descrizione del lavoro

BSP Pharmaceuticals S.p.A., a CDMO, seeks a Microbiological Quality Control specialist to join its GMP environment. You will operate analytical equipment, perform microbiological analyses of materials and finished products, and report anomalies to the supervisor.

Requirements include a biology/biotech degree and prior QC experience; GMP background is preferred. Salary is assessed on a case-by-case basis (RAL 33-38K). BSP promotes an inclusive workplace and equal opportunity for all.

Competenze

• Must have degree in biology/biotechnology or related field.
• Prior microbiological quality control experience in GMP settings.
• GMP environment experience preferred.

Mansioni

• Operate and monitor analytical equipment in the laboratory.
• Perform biological and microbiological analyses of raw materials and non-sterile finished products.
• Perform sterility testing within isolator systems and report anomalies.
• Manage, document, and perform microbiological validation activities.
• Prepare, issue, and review laboratory documentation.
• Inspect containers from simulated filling processes and dispose accordingly.
• Prepare sterilized culture media and perform related controls.
• Support material evaluation and documentation for analytical activities.
• Maintain lab instruments, materials, and working environment.
• Handle waste disposal and ensure compliance with EHS duties.

Conoscenze

Microbiological Quality Control

Formazione

Degree in Biology/Biotechnology or related field

Descrizione del lavoro

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

• Operate and monitor the analytical equipment available in the laboratory.
• Perform biological and microbiological analyses of raw materials and non-sterile finished products in accordance with current analytical methods, promptly reporting any anomalies to the supervisor.
• Perform sterility testing within isolator systems and ensure their proper care and maintenance in accordance with current analytical procedures.
• Manage, document, and perform all microbiological validation activities.
• Prepare, issue, and review laboratory documentation.
• Perform visual inspection of containers from simulated filling processes (Media Fill) and ensure their proper disposal.
• Prepare and sterilize culture media and perform the related controls in accordance with current SOPs.
• Support the evaluation and selection of materials to be purchased for analytical activities and manage the related documentation.
• Maintain laboratory instruments, materials, and the working environment, promptly reporting any anomalies to the supervisor.
• Manage waste disposal and, where required, its inactivation.
• Fulfill EHS (Environment, Health and Safety) duties and responsibilities in accordance with Article 20 of Italian Legislative Decree 81/08, as amended and supplemented, regarding employees’ obligations.

Requisiti

• Degree in Biology, Biotechnology, or a related field.
• Previous experience in Microbiological Quality Control.
• Previous experience in a GMP environment is preferred.

RAL 33-38K (Salary is assessed on a case-by-case basis, depending on the candidate’s experience)

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.We are BSP.