Contract Manufacturing Manager

Position Title: Contract Manufacturing Manager
Work Location: Frankfort, KY 40601
Assignment Duration: 6 Months
Work Arrangement: Onsite
Note: Work will be performed onsite at an external manufacturing site near Lexington, KY ( 40508)

Duties:

• 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 on-site 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

Education :

• B. Sc in related scientific discipline