Contract Manufacturing Manager
Not Disclosed•TemporaryOn-site
location_on8101, Hatton Road, Hatton, Shelby County, Kentucky, 40601, United States
About the Role
This 6-month onsite assignment is based at an external manufacturing site near Frankfort, KY. The Contract Manufacturing Manager serves as the primary Person in Plant, acting as the central point of contact for all communications regarding drug product (DP) manufacturing. In this dynamic environment, you will provide critical oversight to ensure product quality, on-time manufacturing, and the availability of products for forward processing.
You will be responsible for managing exceptions and providing technical support for small molecule DP manufacturing operations, including granulation, blending, compression, and coating. The role requires active participation in risk-based approaches, such as FMEA, to assess process performance and mitigate risks. As the main on-site contact, you will escalate issues as needed and seek cross-functional alignment with CMC, regulatory, MSAT, and quality functions across multiple countries and time zones to maintain operational efficiency.
Work location
Work model: On-site
8101, Hatton Road, Hatton, Shelby County, Kentucky, 40601, United States
Kentucky
Key Responsibilities
- check_circleServe as primary Person in Plant to provide oversight during drug product manufacturing
- check_circleOversee and support exception management during manufacturing operations
- check_circleProvide technical support and oversight of small molecule drug product operations
Similar Job Opportunities
Frequently asked questions about Contract Manufacturing Manager at SPECTRAFORCE
What does a Contract Manufacturing Manager at SPECTRAFORCE do?expand_more
A Contract Manufacturing Manager at SPECTRAFORCE is responsible for the following: Serve as primary Person in Plant to provide oversight during drug product manufacturing; Oversee and support exception management during manufacturing operations; Provide technical support and oversight of small molecule drug product operations; and Participate in FMEA and risk-based approaches to assess process performance.
What are the requirements for this Contract Manufacturing Manager role?expand_more
SPECTRAFORCE is looking for candidates who meet the following requirements: Minimum 7-10 years of experience in Quality / Technical role; Strong knowledge of Good Manufacturing Practices (GMP); and B. Sc in related scientific discipline.
Where is the Contract Manufacturing Manager role at SPECTRAFORCE located?expand_more
Contract Manufacturing Manager at SPECTRAFORCE is based in 8101, Hatton Road, Hatton, Shelby County, Kentucky, 40601, United States. This is a on-site role.
Is this Contract Manufacturing Manager job remote, hybrid, or on-site?expand_more
SPECTRAFORCE has listed this Contract Manufacturing Manager role as on-site.