Manufacturing Associate I (DS) -3rd Shift

Amneal • Chicago, IL

1d • Onsite

About The Position

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

The position performs a range of manufacturing operations, monitors product quality, handles materials and equipment, maintains cleanrooms, and completes manufacturing and quality documentation. It also supports audits and regulatory inspections and reports shift-related nonconformances or events to the Supervisor.

Training is scheduled on Shift B (first shift), 9:00 AM to 5:30 PM CST, for the first 14 days. The regular schedule is Shift D (third shift), 10:00 PM to 6:30 AM CST. Overtime, holidays, and weekends are required as process needs dictate. The hourly rate 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 positions have access to a flexible benefits program, including 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 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 manage manufacturing demands and priorities.
• Ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
• Basic problem identification and troubleshooting skills for 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.
• Computer system experience or skills involving systems such as Delta, PCR, POMS, LIMS, or SAP.
• Knowledge of GMP, GDP, and safety requirements.
• Ability to work a schedule driven by process requirements, including support outside normal shift hours and on weekends when needed.
• Ability to move around the facility to reach equipment, push and pull containers, and lift at least 25 pounds; frequent movement of 25–50 pounds on carts and movement of 100–250 pounds with assistance.
• Ability to stand for long periods.
• Ability to produce neat, legible handwritten documentation.

Nice To Haves

• Aseptic techniques and cleanroom manufacturing experience.
• Associate degree or higher in Biology, Chemistry, Biotechnology, or a related field, if applying via the high-school-diploma-and-industry-experience pathway.
• 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 perform manufacturing work, maintain quality data, meet production goals and timelines, and minimize downtime and 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, in accordance with EHS guidelines.
• Remove used and soiled materials from manufacturing areas.
• Complete 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-related nonconformances and 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: High school or GED