Manufacturing Associate (1st/2nd Split Shift)
Location: Chicago, IL 60616 — Near White Sox Stadium
Address: 3440 S. Dearborn St., Chicago, IL 60616
Pay
$26–$30/hour, based on experience
Schedule
Rotating Split Shift
- 1st Shift: 6:00 AM–2:30 PM
- 2nd Shift: 2:00 PM–10:30 PM
Schedule rotates every 2 weeks
About the role
Our client is seeking a Manufacturing Associate to support the manufacturing of biotechnology products for clinical and commercial use. This role will work within a cGMP manufacturing environment and perform both upstream and downstream manufacturing activities, with a strong emphasis on downstream processing. The ideal candidate will have 1–5 years of biotechnology manufacturing experience, preferably within a pharmaceutical or biotech environment. Candidates with strong technical foundations and transferable manufacturing experience from other industries may also be considered. This is a hands-on manufacturing role—not an R&D or benchtop laboratory position—and involves working with large-scale equipment and processes.
Responsibilities
- Follow work instructions, production specifications, and SOPs to complete manufacturing activities safely, accurately, and efficiently.
- Perform weighing and dispensing of raw materials.
- Prepare media and buffers.
- Set up and operate filtration systems, including dead-end, depth, and tangential flow filtration (TFF).
- Support upstream processes including inoculation, fermentation, harvest, and homogenization.
- Set up and operate chromatography columns and skids.
- Perform aseptic final filtration of intermediates and drug substances.
- Operate and monitor manufacturing equipment using PLC controls and HMI interfaces.
- Perform in-process testing, including pH, conductivity, spectroscopy, and filter integrity testing.
- Monitor manufacturing processes and product quality while maintaining production timelines.
- Troubleshoot equipment and manufacturing process issues and escalate concerns as appropriate.
- Complete batch records and other required cGMP documentation accurately and in a timely manner.
- Perform documentation reviews for completeness and accuracy.
- Verify raw materials and commodities and maintain accurate inventory records in MES.
- Perform routine inventory counts and adjustments.
- Report nonconformances, deviations, and other manufacturing events to supervisors and assist with investigations as needed.
- Communicate processing and sampling timelines with supporting departments and stakeholders.
- Participate in shift handoffs to ensure smooth transitions and uninterrupted operations.
- Follow cleanroom gowning and aseptic practices while working in controlled and classified environments.
- Perform routine cleaning and sanitization of manufacturing areas and equipment.
- Properly handle and dispose of chemicals, buffers, and other hazardous materials in accordance with EHS requirements.
- Assist with technology transfer from Process Development into cGMP manufacturing.
- Identify opportunities to improve manufacturing efficiency, reduce waste, and minimize downtime.
- Train and support other employees and help delegate tasks when appropriate.
- Follow all company, safety, quality, and FDA cGMP requirements.
Requirements
- 1–5 years of hands-on biotechnology manufacturing experience preferred.
- Experience in upstream and/or downstream processing.
- Experience with biotech/pharmaceutical manufacturing strongly preferred.
- Candidates from other industries may be considered if they have a strong technical foundation and transferable manufacturing experience.
- R&D/benchtop laboratory experience alone is not a fit for this position.
- Associate degree or higher in Biology, Chemistry, Biotechnology, or a related scientific field preferred.
- Equivalent combination of education and 2–4 years of relevant industry experience may be considered.
- Previous aseptic processing and cleanroom manufacturing experience preferred.
- Ability to work with large-scale manufacturing equipment and systems.
Skills
Experience with some of the following is highly desirable:
- 250L bioreactors
- Fermentation and inoculation
- Harvest and homogenization
- Chromatography columns and skids
- Tangential flow filtration (TFF)
- Depth and dead-end filtration
- Aseptic filtration and sampling
- Filter integrity testing
- Media and buffer preparation
- Mixing systems
- Weighing and dispensing
- pH, conductivity, and spectroscopy testing
- PLC/HMI systems
- MES/LIMS/SAP or similar manufacturing systems
- cGMP documentation and batch records
About the ideal candidate
The ideal candidate is a hands-on biotech manufacturing professional who is comfortable working with large-scale equipment and following detailed cGMP procedures. Candidates should be comfortable working in a cleanroom environment, troubleshooting manufacturing processes, documenting their work accurately, and collaborating across shifts and departments. This is an excellent opportunity for someone with 1–5 years of upstream/downstream biotech manufacturing experience who is looking to continue building their career in a cGMP production environment.
Position Type: 5 month Contract-to-Hire