GID Technician

About the role

Location: Verona, WI. Assist in the industrial development, process, and product improvement of viral, bacterial, parasitic and/or recombinant vaccines of licensed and unlicensed vaccines. Within the assigned internal site, he/she oversees the manufacturing and/or analytical testing of development and first commercial batches with a yearly vision.

Responsibilities

• Development & Process Transfer Sub-Family Industrialization Strategy Definition and Management: Executes the manufacturing & testing according to the industrial development and process transfer rational (including technical, financial, and regulatory aspects) to anticipate industrial.
• Assist in the development of state-of-the-art, robust, and cost-effective biological production processes from laboratory to industrial scale including roller bottles, multi-plate cell culture systems, bioreactors, inactivation and downstream processing for new and existing products.
• Batch Manufacturing Preparation: Orders, receives & identifies the materials and components; manages inventory; tests technical feasibility at lab scale; participates in industrialization process meetings.
• Risk Assessments: Provides inputs in risk analysis phase (Manufacturing, EHS) and participates in risk assessment meetings.
• Process Improvement: Participates in executing GID projects as assigned; assists in optimizing existing processes; carries out dedicated laboratory activities in process improvement according to relevant rules; writes process‑related study protocols, reports, SOPs and manufacturing directions; prepares summaries of test results for use in GID monthly summaries and/or reports.
• Batch Manufacturing: Ensures correct batch manufacturing execution and adjusts process parameters if needed during batch manufacturing; writes batch manufacturing report; ensures correct sampling plan implementation; submits samples to QC labs and summarizes analytical results and writes draft validation reports; supports QC assay transfer as well as optimization & troubleshoot activities; carries out dedicated laboratory activities in technology transfer processes.
• Training & Tech Transfer: Participates and assists in the transfer of processes into Industrial Operations; participates in designing/leading training sessions for production operators to explain product manufacturing process and critical requirements; participates in writing technical transfer draft report.
• Production & RD Support: Performs laboratory work as assigned on viral, bacterial, parasitic and/or recombinant vaccine projects.
• Lab Management: Ensures labs preventive maintenance & qualification and updates user guides/protocols for GID; ability to understand and use basic equipment autonomously and all complex equipment under supervision; ensures relevant quality standards and regulations are followed during activities; defines/completes studies and manages daily work according to priorities (including laboratory experiments, inventory management, data management, documentation/reporting).
• Internal audit & Inspection: Updates and writes instructions and forms according to relevant quality standards; provides inputs to answer internal/external audit & inspections queries; participates in the trials plans proposal and execution to be performed for change control activities; provides inputs for concerned change control processes led by QA; suggests the improvement of industrial lab practices.

Requirements