The role involves developing and executing technology transfer strategies for sterile injectable products like insulin from process design to regulatory approval
Job Summary
The role involves developing and executing technology transfer strategies for sterile injectable products like insulin from process design to regulatory approval.
Candidates must lead cross-functional teams to coordinate with Contract Manufacturing Organizations (CMOs) and ensure compliance with global health authority inspections.
The position requires conducting comprehensive risk analyses, including FMEA specific to insulin processes, and managing validation batches on time.
Matching Summary
The role involves developing and executing technology transfer strategies for sterile injectable products like insulin from process design to regulatory approval.
Skills & Requirements
Must-have
3 years sterile production experience
Pharmaceutical manufacturing background
Cross-functional team management
GMP compliance knowledge
Aseptic filling process expertise
FMEA risk analysis implementation
CMO collaboration and coordination
Nice-to-have
Excellent communication skills
Strong troubleshooting abilities
High attention to detail
Fast-paced environment adaptability
Leadership in complex regulated settings
Key Requirements
Degree in Pharmaceutical or Chemical Engineering
Minimum 3 years in sterile injectable manufacturing
Experience with aseptic preparation and filling lines