GID Technician (Vaccine Development & Process Transfer)

About the role

Ceva is looking for a GID Technician in Verona, Wisconsin to support the industrial development, process and product improvement of viral, bacterial, parasitic and recombinant vaccines, licensed and unlicensed. The role covers the manufacturing and analytical testing of development and first commercial batches, with a yearly view of the work.

Key responsibilities

• Define and manage the industrialization strategy, covering technical, financial and regulatory aspects, and help move biological production processes from lab to industrial scale (roller bottles, multi-plate cell culture, bioreactors, inactivation and downstream processing).
• Order, receive and identify materials, manage inventory and test technical feasibility at lab scale; take part in industrialization meetings.
• Contribute to manufacturing and EHS risk assessments and process improvement projects.
• Write study protocols, reports, SOPs and manufacturing directions, prepare test result summaries and draft validation reports, and support QC assay transfer and troubleshooting.
• Ensure correct batch manufacturing, sampling and reporting, and carry out laboratory work in technology transfer and training sessions for production operators.
• Maintain lab equipment, keep user guides and protocols up to date, and follow quality standards and regulations.
• Support internal audits and inspections, contribute to change control and suggest improvements to industrial lab practices.

Required profile

• Bachelor's degree in Microbiology, Biology, Chemistry, Pharmacology or a related field.
• At least 2 years of experience in aseptic processing, fermentation, cell culture and assays in research or manufacturing is preferred.
• Basic microbiology, chemistry, tissue culture and virus titration knowledge, or prior virology experience, is a plus.
• Ability to read, write and communicate in English; lifting up to 50 pounds and standing for long periods; clean room laboratory setting; up to 5% travel.

Required skills

• Solid knowledge of GMP procedures and good communication skills.
• General microbiology: virology and bacteriology, titration, purification, inactivation; tissue culture (cell lines, chicken embryo fibroblasts).
• Regulatory knowledge: 9 CFR, USDA Vet. Memorandum 800s, SAM, CVB notices; biosafety (BMBL).
• Laboratory study design, data analysis and statistics; technical writing; Microsoft Office Suite.