Sterile Manufacturing Associate

Job Description

Sterile Manufacturing Associate - Aseptic Fill (MFG I/II/III)

Chicago, IL - Full-Time, Permanent

We are searching for multiple Drug Product Manufacturing Associates with a leading biologics manufacturer in Chicago, IL. Multiple levels available - MFG I, II, and III. Full-time, permanent position - Rotating 1st and 2nd shift schedule.

You will be working within the Drug Product manufacturing team, executing formulation, filtration, and aseptic filling operations for clinical and commercial biologics in a cGMP cleanroom environment.

What you'll be doing:

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• Executing aseptic filling operations with strong aseptic technique in ISO 5/6/7/8 classified environments
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• Formulation and filtration of drug product, including filter integrity testing
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• Operating autoclave, part washer, syringe filler, mixing systems, and peristaltic pumps
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• pH, conductivity, and weight calibration and verification
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• Media and buffer preparation, weighing and dispensing of materials
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• Completing batch records and cGMP documentation accurately and on time
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• Line inspection and line clearance across ISO classified areas
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• Reporting non-conformances and deviations to the shift supervisor
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What you need:

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• MFG I: 0-2 years cGMP aseptic/cleanroom manufacturing experience
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• MFG II: 2-4 years cGMP aseptic/cleanroom manufacturing experience
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• MFG III: 5+ years cGMP aseptic/cleanroom manufacturing experience
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• Experience with autoclave, filling machines, and aseptic technique preferred
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• Comfortable with batch records and GMP documentation
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• Associate degree or higher in Biology, Chemistry, Biotechnology, Pharmacy or related field - or equivalent industry experience
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Annual bonus plus overtime & relocation package available.

Apply directly or get in touch to discuss.