Manufacturing Associate I (DS) -3rd Shift

Amneal India • Chicago, IL

1d • $25 - $30 • Onsite

About The Position

The Manufacturing Associate is a hands-on production position responsible for manufacturing biotechnology products for clinical and commercial human use. The employee executes upstream fermentation and downstream purification processes for microbial-based biosimilars, applying aseptic techniques in controlled and classified environments that require cleanroom and some aseptic gowning. The role requires compliance with company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other applicable government requirements.

The position follows a third-shift schedule of 10:00 PM to 6:30 AM CST after 14 days of first-shift training from 9:00 AM to 5:30 PM CST. Overtime, holidays, and weekends are required based on process requirements. The position is performed in GMP cleanrooms and laboratories and involves handling manufacturing equipment and materials, completing extensive documentation, and meeting production quality goals and timelines.

The hourly pay range is $25.00–$30.00, with a short-term incentive opportunity such as a bonus or performance-based award within the first 12 months. Eligible employees may choose from health and insurance benefits and receive a 401(k) matching contribution, along with employee well-being programs.

Requirements

• Associate degree or higher in Biology, Chemistry, Biotechnology, or a related field, or a high school diploma and 1–2 years of industry experience.
• Ability to understand and follow written and verbal instructions.
• Ability to understand technical information, procedures, batch records, and other documents in English.
• Ability to learn to use hand and electrical tools properly and efficiently.
• Ability to work in a fast-paced environment and handle manufacturing demands and priorities.
• Excellent interpersonal skills and effective communication with peers and supervisors.
• Reasoning skills.
• Ability to operate complex systems and equipment under minimum supervision in accordance with current GMPs, SOPs, and safety guidelines.
• Basic ability to identify problems and troubleshoot equipment and manufacturing processes.
• Ability to work independently within prescribed guidelines or as a team member, and to follow detailed directions.
• Basic computer skills, including Microsoft Word, Excel, and PowerPoint.
• Ability to operate and understand data-management software and computer systems such as Delta, PCR, POMS, LIMS, and SAP.
• Knowledge of GMP, GDP, and safety requirements.
• Ability to lift at least 25 lbs.; frequent movement of 25–50 lbs. on carts and movement of 100–250 lbs. with assistance.
• Ability to move around the facility, push and pull containers, and stand for long periods.
• Ability to produce neat and legible handwritten documentation.
• Availability to work overtime, holidays, and weekends as required by process requirements.

Nice To Haves

• Aseptic techniques and cleanroom manufacturing experience.
• Knowledge of biotechnology operations and equipment, including aseptic filtration systems, aseptic sampling, filter integrity testing, fermentation and inoculation processes, chromatography columns, mixing systems, and weighing scales.

Responsibilities

• Follow work instructions, production specifications, and SOPs to meet production goals and timelines, maintain quality data, and minimize downtime or delays.
• Weigh and dispense materials; prepare media and buffers.
• Operate dead-end, depth, and tangential flow filtration systems.
• Perform cytokine cell inoculation, fermentation, harvest, and homogenization.
• Set up and operate chromatography columns.
• Perform aseptic final filtration of intermediates and drug substances.
• Monitor product quality using PLC controls, HMI interfaces, integrity testing, and in-process tests such as pH, conductivity, and spectroscopy.
• Handle and discard hazardous materials in accordance with EHS guidelines and remove used or soiled materials from manufacturing areas.
• Perform daily and weekly cleaning of cleanrooms and equipment.
• Track, request, stage, and verify raw materials and commodities; enter related data into MES daily.
• Complete batch records and other cGMP documentation accurately and promptly in compliance with good documentation practices, including ALCOA++.
• Revise solution preparation batch records, SOPs, protocols, and logbooks.
• Support quality audits and regulatory inspections.
• Report nonconformances or events occurring during the shift to the Supervisor.
• Comply with safety, cGMP, and company policies, practices, and procedures.
• Perform other functions as required or assigned.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Health and insurance benefits for eligible positions.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree