Senior Clinical Manufacturing Lead II
Core
Lead production teams to produce high quality solid dosage form clinical supplies utilizing state-of-the-art technologies and develop reliable manufacturing processes.
Role type
Senior Clinical Manufacturing Lead
Builds
GMP compliant clinical supplies (solid dosage forms)
Domain
Biopharmaceuticals / Clinical Manufacturing
Required skills
cGMP compliance, batch record management, pilot plant operations, formulation development collaboration, technical troubleshooting, project coordination, personnel supervision, process improvement
Preferred skills
Experience in cGMP environment
Technologies
Pilot plant equipment, batch record systems
Responsibilities
Lead manufacturing activities and prepare/close out batch records; Supervise pilot plant technicians and provide performance reviews; Collaborate with formulators on development activities; Provide technical guidance and troubleshoot manufacturing issues; Ensure compliance with cGMP requirements and safety policies; Coordinate with CMC team to meet project commitments.
Seniority
Senior, hands-on IC with supervision responsibilities
