Senior Manufacturing Biotech Associate
Core
Senior team member responsible for all procedures and processes associated with the manufacture of Drug Substance in a single-use biotech facility.
Role type
Senior Manufacturing Biotech Associate (GMP)
Builds
Drug Substance (Biologics)
Domain
Biopharmaceutical Manufacturing / Downstream Processing
Required skills
GMP compliance, Downstream process expertise, Root cause analysis, Lean Six Sigma, MES/SAP/DeltaV proficiency, Team mentorship, Shift management
Preferred skills
Upstream process knowledge, Kanban/JIT/5S methodologies, Troubleshooting complex problems
Technologies
MES, SAP, DeltaV, GLIMS, PROCAL
Responsibilities
Execute and optimize Drug Substance manufacturing procedures, Train and mentor less experienced team members, Lead local work teams and organize production schedules, Participate in shift handovers and Tier meetings, Conduct inspections, GEMBA walks, and improvement projects, Perform EBR and documentation reviews, Utilize Lean Six Sigma tools for continuous improvement.
Seniority
Senior, hands-on IC with mentorship responsibilities