Tech, Operations
Core
Execute automated recipes and production processes for biologic drug substance manufacturing, including inoculation, cell culturing, filtration, and purification.
Role type
Biotech Technician Associate (Manufacturing IC)
Builds
Biologic drug substances for Clinical Supply, Registration, and Commercial Launch
Domain
Biopharmaceuticals / Regulated Manufacturing
Required skills
Biopharmaceutical Manufacturing, Good Manufacturing Practices (GMP), Manufacturing Operations, Manufacturing Processes, Manufacturing Quality Control, Media Preparation, Process Improvements, Standard Operating Procedure (SOP), Equipment Maintenance, Manufacturing Documentation
Preferred skills
Lean Six Sigma, Emergency Response Team (ERT) training
Technologies
Automated recipes, paperless technology, Enablon
Responsibilities
Execute automated recipes for drug substance production; Set up single-use equipment between runs; Optimize processing activities using lean techniques; Support operations team to deliver on KPIs; Complete Good Catches to support safety culture; Mentor new staff members; Participate in process deviation reviews and Gemba walkdowns; Act as an Emergency Response Team member.
Seniority
Mid-level, hands-on IC