Spclst, Process Engineering (MS&T) - Upstream or Downstream
Core
Specialist in Manufacturing Science & Technology (MS&T) supporting process engineering, NPI, and validation for biologics drug substance manufacturing.
Role type
Specialist IC process engineer (biologics)
Builds
biologics-based medicines (immuno-oncology)
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
upstream cell culture, downstream purification, process qualification and validation, change control management, CAPA investigations, experimental design, data analysis, Lean Six Sigma, FMEA, regulatory compliance (cGMP)
Preferred skills
technology transfer, commercial drug substance manufacturing, regulatory filing
Technologies
cGMP, Lean Six Sigma, FMEA, SPC, MVDA, PPQ
Responsibilities
Support development and PPQ batches, facilitate investigations and root cause analysis, participate in audits and inspections, interpret trends in commercial process monitoring, author batch documentation and regulatory submissions, lead continuous improvement initiatives.
Seniority
Specialist, hands-on IC
