GID Technician
Listed on 2026-09-14
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Manufacturing / Production
Regulatory Compliance Specialist, Pharmaceutical Manufacturing
Role
Support industrial development and process transfer of viral, bacterial, parasitic, and recombinant vaccines within a manufacturing site, focusing on process optimization, batch manufacturing, and technology transfer.
ResponsibilitiesDevelop scalable biological production processes, prepare and execute manufacturing batches, perform risk assessments, optimize existing processes, write protocols and reports, and support quality and regulatory compliance. Collaborate with R&D, QA, QC, and manufacturing teams, and participate in audits and change control activities.
RequirementsBA/BS in Microbiology, Biology, Chemistry, or related; minimum 2 years’ experience in aseptic processing, fermentation, cell culture, or assays in research or manufacturing.
SkillsKnowledge of GMP, microbiology, virology, tissue culture, data analysis, and technical writing; experience with upstream/downstream processing, risk assessments, and process validation.
PreferredVirology expertise, experience with vaccine development, and familiarity with USDA and 9 CFR regulations.
High-ValueFocus on vaccine development for viral, bacterial, parasitic, or recombinant products; process transfer, manufacturing scale-up, and compliance with regulatory standards.
LocationVerona, WI; travel up to 5%.
Work setupIn a cleanroom manufacturing laboratory environment.
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