Manufacturing Associate II -3rd Shift

Amneal • Chicago, IL

1d • Onsite

About The Position

The Manufacturing Associate is a hands-on production role responsible for manufacturing biotechnology products for clinical and commercial human use. The position 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 employee must follow Kashiv BioSciences policies and procedures, FDA current Good Manufacturing Practices (cGMP), and applicable government requirements.

The role involves following work instructions and SOPs to meet production goals, maintain quality data, and minimize delays. Duties include material weighing and dispensing; media and buffer preparation; filtration; cell inoculation, fermentation, harvest, and homogenization; chromatography column setup and operation; and aseptic final filtration. The associate monitors product quality using PLC controls, HMI interfaces, integrity testing, and in-process tests. The position also includes material and inventory tracking, cGMP documentation, cleaning and housekeeping, safe handling of hazardous materials, and support for audits and inspections.

The position works in GMP cleanrooms and laboratories. The posted schedule begins with 14 days on Shift B, 9:00 AM to 5:30 PM CST, followed by Shift D, 10:00 PM to 6:30 AM CST. Overtime, holidays, and weekends are required based on process requirements. The hourly rate is $30.00 to $35.00, with an opportunity for a short-term incentive such as a bonus or performance-based award within the first 12 months. Eligible positions receive a flexible benefits program that includes health and insurance benefits and a 401(k) matching contribution.

Requirements

• Associate degree or higher in Biology, Chemistry, Biotechnology, or a related field, or a high school diploma and at least 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 manage manufacturing demands and priorities.
• Effective interpersonal and communication skills with peers and supervision.
• Ability to produce extensive handwritten documentation in accordance with current Good Manufacturing and Good Documentation Practices.
• Ability to operate complex systems and equipment in accordance with cGMP, 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 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.
• Must be able to move around the facility to reach equipment, push and pull containers, and lift at least 25 lbs.
• Must be able to frequently move 25–50 lbs on carts and move 100–250 lbs with assistance.
• Must be able to stand for long periods and occasionally bend, squat, kneel, stoop, push, pull, and reach; frequent repetitive motions are required.
• Must work overtime, weekends, and holidays when required by process requirements.

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 to perform manufacturing duties, maintain quality data, meet production goals and timelines, and minimize downtime or delays.
• Weigh and dispense materials and 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 testing such as pH, conductivity, and spectroscopy.
• Handle and discard hazardous materials, including buffers and chemicals, according to EHS guidelines.
• Remove used and soiled materials from manufacturing areas and follow daily and weekly cleanroom and equipment cleaning routines.
• Track, request, stage, and verify raw materials and commodities, and 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 shift nonconformances or events 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.
• Flexible benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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