Lead clinical supply manufacturing, scientific rigor of processes, and enable flexibility and speed of the company's pipeline
Job Summary
Lead clinical supply manufacturing, scientific rigor of processes, and enable flexibility and speed of the company's pipeline.
Own FLEx interactions across CMC project teams, and especially the manufacturability assessment of first in human formulations.
Provide technical oversight and direction to immediate and indirect team, to support continuous improvement efforts while building operational and technical excellence.
Matching Summary
Lead clinical supply manufacturing, scientific rigor of processes, and enable flexibility and speed of the company's pipeline.
Salary
$173,200.00 - $272,600.00; Bonus/Equity: eligible for annual bonus and long-term incentive; Benefits: medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
GMP drug product processing
Oral solid dosage forms
Process robustness and validation
Root cause analysis
Deviation management
cGMP, FDA, EMA regulatory requirements
Nice-to-have
Drive new technology strategy
Scientific understanding and capability build
Enhance professional image
Work effectively with diverse teams
Mentoring capabilities
Key Requirements
Bachelor of Science degree with 14 years relevant experience
Master’s degree with 10 years relevant experience
PhD degree with 8 years relevant experience
Extensive knowledge in GMP drug product processing
Subject matter expert in drug deliveries/manufacturing technologies