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Astrix

Downstream Manufacturing Associate

Astrix, Morrisville, North Carolina, United States, 27560

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This range is provided by Astrix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range $35.00/hr - $42.00/hr

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.

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!

Seniority level Associate

Employment type Contract

Job function Manufacturing and Research

Industries Pharmaceutical Manufacturing

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