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Drug Product Manufacturing Associate I - III

Pharma Universe

Chicago, illinois


Job Details

Full-time


Full Job Description

Manufacturing Associates (Levels I, II, and III) for a Drug Product Team, specializing in the aseptic filling and packaging of biologic products in a controlled, cGMP-compliant environment. Manufacturing Associates will play a critical role in ensuring the successful production of sterile drug products by performing operations that include material preparation, aseptic filling, equipment setup, and final packaging.

Key Responsibilities

  • Manufacturing Associate I: Support routine aseptic filling and packaging operations, assist with equipment setup and cleaning, monitor quality through visual inspections, and document activities following SOPs.
  • Manufacturing Associate II: Independently execute and monitor aseptic processes, lead equipment setup and minor maintenance, ensure documentation accuracy, and mentor junior associates.
  • Manufacturing Associate III: Lead and oversee aseptic operations, resolve technical and operational challenges, drive process improvements, and train team members while supporting audits and validation activities.

Qualifications

  • Level I: High school diploma or equivalent; 0–1 year of GMP experience; knowledge of aseptic techniques is a plus.
  • Level II: Associate/Bachelor's degree preferred; 1–3 years of aseptic GMP experience; proficiency with sterile equipment.
  • Level III: Bachelor's degree preferred; 3+ years in aseptic manufacturing with leadership experience and expertise in GMP compliance.

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