Downstream Manufacturing Associate

Position **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, NCContract (potential for conversion)Multi-shift availability (1st and 2nd shifts)** $35-$42/hourLooking for experience with AKTAKey **Perform manufacturing operations from cell expansion through purification following MBRs and SOPsPrepare buffers and support solutions; pack, qualify, and clean chromatography columnsOperate and maintain analytical and manufacturing equipment in cleanroom environmentsEdit and maintain SOPs, logbooks, and batch documentation in accordance with GDPCoordinate with supply chain on raw material delivery, cleaning, and stockingSupport waste decontamination and removal following EHS standardsEnter production data into databases and assist with batch closeout activitiesEnsure compliance with cGMP, GDP, CFRs, and internal quality policiesCollaborate with cross-functional teams on tech transfers and troubleshooting production issuesA.S. degree, Biomanufacturing certification, or equivalent experienceFamiliarity with FDA regulations, cGMP, and GDP documentation standardsEffective communication skills and ability to work collaboratively in a teamFlexibility to work varied shifts including nights and weekendsAbility to lift 25 lbs routinely and up to 50 lbs occasionally**B.S. in Biochemistry, Bioengineering, Chemical Engineering, or related field2+ years of GMP biologics manufacturing experience (e.g., cell culture, purification, aseptic fill/finish)Experience with single-use systems and GMP batch record managementThis 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!

Created: 2025-05-11