Manufacturing & MBR Specialist, mRNA Manufacturing
Core
Manufacturing Specialist for mRNA Manufacturing Process Unit, responsible for formulation of mRNA Drug Substances & Drug Products and acting as SME for facility, processes, and services.
Role type
Manufacturing Specialist (mRNA)
Builds
mRNA Drug Substances and Drug Products
Domain
Life Sciences / Biopharmaceuticals / mRNA Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP Manufacturing, Upstream and Downstream processes, Deviation management, CAPA, Change Control, Documentation (SOPs, Protocols, Batch Records), Equipment qualification, Root cause analysis
Preferred skills
Yellow or Green Belt Certification
Technologies
GMP, mRNA Manufacturing processes
Responsibilities
Manage Facility/Equipment/Documentation/Process issues, Support Quality Team on deviation management, Manage Deviation/CAPA/Change Control records, Issue and review manufacturing documentation, Issue Master Batch Records, Collaborate on new Equipment & Consumables specifications, Plan and monitor commissioning and qualification activities, Participate in client visits and audits, Promote Trainings and Process Courses, Identify Continuous Improvement & Cost Saving Projects
Seniority
Mid-level, hands-on IC