Senior Associate Process Engineer (Contract)
Core
Provide process science support for GMP manufacturing, technology transfers, development studies, characterization, and validation for cell and gene therapy, mRNA, and viral vector programs.
Role type
Senior Associate Process Engineer (Contract)
Builds
Clinical and commercial stage biotechnology products
Domain
Biopharmaceutical manufacturing (cell and gene therapy, mRNA, viral vectors)
Required skills
GMP manufacturing, aseptic processing, cell culture, process development, validation, lifecycle management, root cause analysis, risk assessment, technical documentation authoring
Preferred skills
Cell and gene therapy experience, drug manufacturing experience, familiarity with Veeva or electronic batch records
Technologies
Veeva, electronic batch records
Responsibilities
Support technology transfers and cGMP manufacturing; Author and review technical documentation (protocols, reports, SOPs); Own and support quality events (deviations, investigations, CAPAs, Change Controls); Assist in root cause determination of process deviations; Support gap analyses and risk assessments for capital projects and tech transfers
Seniority
Senior, hands-on IC