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Downstream Manufacturing Associate

Manufacturing

Morrisville, NC, US

Pay Rate Low: 35 | Pay Rate High: 42

+ Added - 10/07/2025

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Position Summary:

The Downstream Manufacturing Associate 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!

INDBH

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.