Manufacturing Associate I (DS) - Rotating 1st & 2nd Shift

Amneal India • Chicago, IL

5d • $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 role 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 associate must comply with company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other applicable government requirements.

The position follows production instructions and SOPs, maintains quality data, and works to meet production goals and timelines while minimizing downtime. It includes preparing materials, operating manufacturing equipment, monitoring product quality, completing cGMP records, maintaining cleanrooms and equipment, and supporting audits and inspections. Manufacturing schedules are driven by process requirements and may require overtime, weekends, holidays, or work outside normal shift hours. Shift schedules listed include first, second, and third shifts; overtime is paid at time-and-a-half.

The position is performed in GMP cleanrooms and laboratories and involves frequent movement, repetitive motion, lifting, and pushing or pulling containers. The hourly rate is $25.00–$30.00. Eligible employees may receive a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months. The company describes a flexible benefits program that includes health and insurance benefits and a significant 401(k) matching contribution, as well as 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 manage manufacturing demands and priorities.
• Strong interpersonal skills and effective communication with peers and supervisors.
• 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 meet the stated physical requirements, including lifting at least 25 pounds and frequent movement of heavier loads with carts or assistance.

Nice To Haves

• Associate degree or higher in Biology, Chemistry, Biotechnology, or a related field.
• Experience with aseptic techniques and cleanroom manufacturing.
• Knowledge of biotechnology operations and equipment, including aseptic filtration systems, aseptic sampling, filter integrity testing, fermentation and inoculation processes, chromatography columns, mixing systems, and weigh scales.

Responsibilities

• Follow work instructions, production specifications, and SOPs to perform production activities, maintain quality data, meet production goals and timelines, and minimize downtime or delays.
• Weigh and dispense materials and prepare media and buffers.
• Operate filtration systems, including 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 interfaces, integrity testing, and in-process testing 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.
• Follow daily and weekly cleanroom and equipment cleaning routines to maintain required manufacturing conditions.
• Track, request, stage, and verify raw materials and commodities, and enter related data into 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.
• 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