The Director provides strategic and operational leadership for non-sterile manufacturing operations including packaging, inspection, and device assembly
Job Summary
The Director provides strategic and operational leadership for non-sterile manufacturing operations including packaging, inspection, and device assembly.
This role ensures safe, compliant, and efficient execution of manufacturing activities from development through commercialization while driving operational excellence.
Candidates must possess a Bachelor's degree and over 10 years of progressive operations leadership experience in a cGMP-regulated pharmaceutical environment.
Matching Summary
The Director provides strategic and operational leadership for non-sterile manufacturing operations including packaging, inspection, and device assembly.
Skills & Requirements
Must-have
cGMP compliance in regulated environment
leadership of sterile and non-sterile operations
experience with Auto Injector Assembly
management of Oral Solid Dose platforms
oversight of Continuous Manufacturing technologies
Nice-to-have
strong financial and strategic acumen
ability to influence cross-functional stakeholders
experience with automated assembly systems
high-speed packaging line expertise
culture of engagement and continuous improvement
Key Requirements
Bachelor's degree in Engineering or related field
10+ years of pharmaceutical operations leadership experience
Strong understanding of FDA 21 CFR Parts 210/211 and EU GMP
Experience with combination products and medical device manufacturing