QC Microbiology Analyst

BSP Pharmaceuticals S.p.A.; Latina; In loco; EUR 33.000 - 38.000; Tempo pieno

Descrizione del lavoro

BSP Pharmaceuticals S.p.A is a CDMO offering development to manufacturing for cytotoxic and non-cytotoxic therapies. The role covers operating analytical equipment, performing microbiological QC, sterility testing in isolator systems, and maintaining lab documentation in a GMP environment.

Ideal candidates have a biology/biotech degree and prior QC experience. RAL 33-38K; salary is case-by-case based on experience, with onsite work in an established facility.

Competenze

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

Mansioni

• 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 duties and responsibilities in accordance with Article 20 of Italian Legislative Decree 81/08, as amended and supplemented, regarding employees’ obligations.

Conoscenze

Microbiological QC

GMP experience

Formazione

Degree in Biology or Biotechnology

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

Posizione:

• 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)

Altre informazioni:

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.