Manufacturing Associate II -3rd Shift

Amneal • Chicago, IL

1d • $30 - $35 • 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 government requirements.

The associate follows work instructions, production specifications, and SOPs to carry out manufacturing activities, maintain quality data, meet production goals and timelines, and minimize downtime. Duties include preparing materials, media, and buffers; operating filtration systems; performing fermentation and related processes; setting up and operating chromatography columns; and conducting aseptic final filtration. The associate monitors product quality using process controls and testing, handles materials and waste in accordance with EHS guidelines, cleans manufacturing areas and equipment, manages materials and data, and completes cGMP documentation. The role also supports audits and inspections, reports shift events or nonconformances, and performs other assigned functions.

The position works in GMP cleanrooms and laboratories. Shift hours are 10:00 PM to 6:30 AM CST for Shift D, with the first 14 days scheduled 9:00 AM to 5:30 PM CST for Shift B. Overtime, holidays, and weekends are required based on process requirements.

Requirements

• Associate degree or higher in Biology, Chemistry, Biotechnology, or a related field; alternatively, a high school diploma and at least 2 years of industry experience.
• Ability to understand and adhere to 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 manage manufacturing demands and priorities.
• Effective interpersonal and communication skills with peers and supervision; ability to produce extensive written manufacturing documentation.
• Ability to operate complex systems and equipment in accordance with GMPs, SOPs, and safety guidelines under minimal supervision.
• 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 work overtime, weekends, and holidays as required by process needs.
• Ability to move around the facility and push and pull containers; lift at least 25 lbs; frequently move 25–50 lbs on carts; and frequently move 100–250 lbs with assistance.
• Ability to stand for long periods and perform occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and frequent repetitive motions.

Nice To Haves

• Aseptic techniques and cleanroom manufacturing experience.
• Knowledge of biotechnology operations, 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 while maintaining quality data and meeting production goals and timelines.
• Weigh and dispense materials; prepare media and buffers.
• Operate dead-end, depth, and tangential flow filtration systems.
• Perform inoculation, fermentation, harvest, and homogenization of cytokine cells.
• Set up and operate chromatography columns.
• Perform aseptic final filtration of intermediates and drug substances.
• Monitor product quality using PLC controls, HMI interfacing, integrity testing, and in-process tests such as pH, conductivity, and spectroscopy.
• Handle and discard hazardous materials according to EHS guidelines and remove used or soiled materials from manufacturing areas.
• Follow daily and weekly cleaning routines for cleanrooms and equipment.
• Track, request, stage, and verify raw materials and commodities; enter related data in MES daily.
• Complete batch records and other cGMP documentation accurately and promptly in accordance 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 arising 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: Mid Level
• Education Level: Associate degree