Contract Manufacturing Manager

Role: Contract Manufacturing Manager
Location: Frankfort, KY
6 Months + Extension
 
Duties: 

• NOTE: Work will be performed onsite at an external manufacturing site near Lexington, KY
• Provides support to the primary point of contact for all communications pertaining to the drug product manufacturing at an external manufacturing site
• Serve as primary Person in Plant with responsibility to provide oversight during DP manufacturing
• Oversee and support exception management during manufacturing
• Provide technical support and oversight of SM DP manufacturing operations including granulation, blending, compression and coating.
• Participate in FMEA or other risk-based approaches to assess process performance
• Provide PM onsite support to support on time manufacturing and respond to risk
• Act as main onsite contact, escalating as appropriate and seeking cross functional alignment and clarifications as needed to ensure product quality, on time manufacturing and availability of product for forward processing.

Skills:

• Minimum 7-10 years of experience in Quality / Technical role, PM experience is an advantage.
• Strong knowledge of Good Manufacturing Practices (GMP), specifically for small molecule drug product operations
• Ability to effectively manage time, multiple overlapping priorities and progress tasks to meet timeline in a fast pace/dynamic environment.
• Experience working cross-department with CMC, regulatory, MSAT and other quality functions across multiple countries / time zones
• Ability to evaluate and understands quality risk, including risk mitigation
• Computer Skills: PC, including MS Office Suite
• Travel: Occasionally, as required