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 including cell and gene therapies, mRNA, and viral vectors
Domain
Biotechnology / Advanced Therapies / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing, aseptic processing, cell culture, process development, validation, lifecycle management, root cause analysis, risk assessment, gap analysis
Preferred skills
Cell and gene therapy experience, drug manufacturing experience
Technologies
Veeva, electronic batch records
Responsibilities
Write protocols, product impact assessments, root-cause analysis reports, and technical reports; support data collection and charting for non-GMP and GMP batches; own and support quality events such as deviations, investigations, CAPAs, and Change Controls; assist in root cause determination of process-related deviations; support gap analyses and risk assessments for capital projects and tech transfers
Seniority
Senior, hands-on IC