Downstream Manufacturing Associate Job at Astrix, Morrisville, NC

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  • Astrix
  • Morrisville, NC

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!

Job Tags

Contract work, Shift work, Night shift, Day shift, Afternoon shift,

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