Job Description

Position Summary:

The Manufacturing Process Technician is responsible for executing GMP manufacturing processes including upstream and downstream operations, material handling, and batch documentation. This role ensures consistent production of high-quality clinical materials and supports the successful transfer of new processes into manufacturing.

Morrisville, NC

Contract (potential for conversion)

Multi-shift availability (1st and 2nd shifts)

Pay: $35–$42/hour

Looking for experience with AKTA

Key Responsibilities:

• Perform manufacturing operations from cell expansion through purification following MBRs and SOPs
• Prepare buffers and support solutions; pack, qualify, and clean chromatography columns
• Operate and maintain analytical and manufacturing equipment in cleanroom environments
• Edit and maintain SOPs, logbooks, and batch documentation in accordance with GDP
• Coordinate with supply chain on raw material delivery, cleaning, and stocking
• Support waste decontamination and removal following EHS standards
• Enter production data into databases and assist with batch closeout activities
• Ensure compliance with cGMP, GDP, CFRs, and internal quality policies
• Collaborate with cross-functional teams on tech transfers and troubleshooting production issues

Qualifications:

Required:

• A.S. degree, Biomanufacturing certification, or equivalent experience
• Familiarity with FDA regulations, cGMP, and GDP documentation standards
• Effective communication skills and ability to work collaboratively in a team
• Flexibility to work varied shifts including nights and weekends
• Ability to lift 25 lbs routinely and up to 50 lbs occasionally

Preferred:

• B.S. in Biochemistry, Bioengineering, Chemical Engineering, or related field
• 2+ years of GMP biologics manufacturing experience (e.g., cell culture, purification, aseptic fill/finish)
• Experience with single-use systems and GMP batch record management

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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