53Biologics is a CDMO with extensive experience in the production of biologics (pDNA, RNA and proteins). Our services include cell line generation and improvement, process development, scale-up and batch production. Our main mission is to develop the full potential of biotechnology, to get your drugs to market as soon as possible. Due to the rapid growth of our company, we are looking for an Upstream Operator to join a young, multidisciplinary and highly qualified team to work in a leading biotechnology company.

Functions:

• Preparation, start-up, monitoring, control and process development for the production of recombinant proteins, monoclonal antibodies or similar biological molecules in microorganisms.
• Bioreactor handling and scale-up experience.
• Design of experiments for the improvement and optimization of culture media.
• Preparation of technical reports
• Propose and elaborate procedures and instructions in the field of his/her competence.
• Define and manage the technical implementation of projects.
• Participate in technology transfer from external companies.
• Participate in staff training, as well as produce training course material when necessary.
• Participate in internal/external audits as required by the Quality Department.
• Reporting results to the Project Manager or supervisor.
• Comply with all safety standards set out in the job related risk protocol.
• Record any Non-Conformities detected during the production process and participate in the investigation of the same together with the Project Manager.

Requirements:

• Degree or PhD in Chemical or Industrial Engineering, Chemistry, Biotechnology, Biology or equivalent discipline.
• At least 2 years of experience in process development processes for the production of recombinant proteins.
• At least 2 years of experience in the biotech industry, working in the USP area (production of recombinant proteins and monoclonal antibodies), from process development to scale-up.
• Used to work in multidisciplinary teams with interaction with other departments of the company and external customers.
• Experience in providing know-how to ensure proper technology transfer as well as proposing improvements in quality, cost, performance, time and safety.
• Experience in preparing documentation (SOPs, protocols, reports) in accordance with regulatory standards.
• English medium level
• Analytical and problem solving skills
• Communication skills

Type of position: full time Schedule: 8 hour shift Education: Bachelor's Degree/Graduate Degree (Required)

Experience:

• Process for the production of recombinant proteins: 3 years (Required)
• Biotech industry, working in the area of USP: 3 years (Required)

Job location: Face-to-face employment