Downstream Manufacturing Associate Position Available In Wake, North Carolina
Tallo's Job Summary: The Downstream Manufacturing Associate role in Morrisville, NC involves executing GMP manufacturing processes, handling materials, and documenting batches to ensure high-quality clinical materials. This contract position offers $35-$42/hour with potential for conversion, requiring multi-shift availability, familiarity with FDA regulations, effective communication skills, and the ability to lift up to 50 lbs occasionally.
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
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!
