Manufacturing Engineer
Core
Scaling and transferring biopharmaceutical manufacturing processes from development to production, ensuring quality and compliance for nucleic acid therapeutics.
Role type
Manufacturing Engineer (Biopharma)
Builds
Nucleic acid therapeutics and life-saving medicines
Domain
Biopharmaceuticals / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process scale-up, technology transfer, batch record authoring, change control management, deviation investigation, SOP development, CAPA management, root cause analysis, vendor coordination
Preferred skills
GMP facility experience, automated equipment methods
Technologies
Automated equipment methods, batch record systems, change control systems
Responsibilities
Transfer and scale-up new processes from Chemical Development into Manufacturing; Write or review new process documentation including master batch records and automated equipment methods; Coordinate revision of standard operating procedures (SOPs) to support process transfer and scale-up; Generate and review batch summaries for all batches produced; Lead or participate in investigation of major process deviations and provide technical assistance to Quality Assurance; Assist manufacturing with problem-solving and troubleshooting process or equipment issues.
Seniority
Mid-level, hands-on IC