Front Line Manufacturing Manager (Bulk Drug Substance - Upstream) - Night Shift
Core
On-shift front line manager leading manufacturing associates to produce GMP drug substance in a biotechnology plant.
Role type
Senior IC manufacturing manager (upstream)
Builds
GMP drug substance for patients
Domain
Biotechnology / Pharmaceutical manufacturing
Required skills
GMP compliance, cGMP regulations, Lean culture, team leadership, process optimization, CAPA management, aseptic techniques, budget management
Preferred skills
Biotechnology/pharmaceutical plant startup experience, upstream/downstream operations knowledge, performance management, conflict resolution, project management, regulatory requirements understanding, Microsoft/EBR/MES/Delta V proficiency
Technologies
EBR, MES, Delta V, Electronic quality systems
Responsibilities
Ensure safe working environment and cGMP/CFR compliance; Supervise, coach, hire, and develop floor staff; Lead on-floor operations with minimal direction; Define area objectives and lead change efforts; Collaborate with cross-functional teams on production activities; Manage budget and department goals.
Seniority
Senior, hands-on IC