Sterile Manufacturing Associate

Global Life Science Hub; Chicago (IL); On-site; USD 55,000 - 75,000; Full time

Job summary

Global Life Science Hub in Chicago, IL seeks multiple Drug Product Manufacturing Associates (MFG I/II/III) for aseptic fill operations on a rotating 1st/2nd shift. Roles include formulation, filtration, and aseptic filling in a cGMP cleanroom.

Ideal candidates have cGMP aseptic experience corresponding to the level, and an associate degree or higher in biology, chemistry, biotechnology, or related field. Training and full-time permanent positions offered.

Qualifications

• 0–2 years cGMP aseptic/cleanroom manufacturing experience for MFG I
• 2–4 years cGMP aseptic/cleanroom manufacturing experience for MFG II
• 5+ years cGMP aseptic/cleanroom manufacturing experience for MFG III
• Experience with autoclave and filling equipment preferred
• Associate degree or higher in Biology/ Chemistry/ Biotechnology/ Pharmacy or related field or equivalent experience

Responsibilities

• Execute aseptic filling operations with strong aseptic technique in ISO 5/6/7/8 classified environments
• Formulation and filtration of drug product, including filter integrity testing
• Operate autoclave, part washer, syringe filler, mixing systems, and peristaltic pumps
• Calibrate and verify pH, conductivity, and weight
• Media and buffer preparation, weighing and dispensing of materials
• Complete batch records and cGMP documentation on time
• Line inspection and line clearance across ISO classified areas
• Report non-conformances and deviations to the shift supervisor

Skills

Aseptic technique

cGMP compliance

ISO cleanroom experience

Documentation accuracy

Batch records

Education

Associate degree or higher in Biology, Chemistry, Biotechnology, Pharmacy or related field

Tools

Autoclave operation

Filling equipment

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:

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

What you need:

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