Manufacturing Process Expert - Lancesoft : Job Details

Title: Manufacturing Technology/ Process ExpertLocation: Millburn NJ 07041Duration: 05 monthsShift Timing: 09:00 - 17:30Job Description:

• Step into a role where your expertise supports the cutting edge of Radioligand Therapy manufacturing.
• As a Process Expert, you'll be the go-to partner on the shop floor—ensuring each batch is produced safely, efficiently, and in full compliance. You'll lead investigations, drive continuous improvement, and support seamless technology transfers, all while mentoring others and maintaining inspection readiness.
• This is your opportunity to make a meaningful impact in a dynamic, purpose-driven environment where innovation and quality go hand in hand.

Key Responsibilities:• Lead investigations for deviations, including Out Of Specification and Out Of Expectation results• Collaborate cross-functionally to assess deviation impact and identify root causes• Initiate and track CAPAs, ensuring timely resolution and effectiveness verification• Act as change manager for manufacturing change control working cross-functionally to implement process improvements• Escalate deviations according to guidelines and present details clearly, including root cause and CAPAs.• Draft manufacturing documentationEssential Requirements:• Bachelor's degree required, preferably in a scientific discipline• Minimum 1 year's of previous GMP experience is requiredProven background in the pharmaceutical industry with hands-on manufacturing exposure• Strong understanding of deviation management, CAPA processes, and regulatory compliance• Excellent communication and collaboration skills across cross-functional teams• Technical writing skills#J-18808-Ljbffr