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

Amneal • Chicago, IL

4d • 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 employee must comply with company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other government requirements.

The position follows the rotating manufacturing schedule and process requirements, which may require work outside normal shift hours, on weekends, and on holidays. The role is based in GMP cleanrooms and laboratories and involves routine movement around the facility, equipment operation, material handling, and physical activity.

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.
• Excellent interpersonal skills and effective communication with peers and supervision.
• Ability to operate complex systems and equipment in accordance with cGMP, 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 part of a team, and to follow detailed directions.
• Basic computer skills, including Microsoft Word, Excel, and PowerPoint.
• Ability to operate and understand data management software.
• Knowledge of GMP, GDP, and safety requirements.
• Ability to move around the facility to reach equipment; push and pull containers; and perform bending, squatting, kneeling, stooping, pushing, pulling, reaching, and frequent repetitive motions.
• Ability to lift at least 25 pounds, frequently move 25–50 pounds on carts, and frequently move 100–250 pounds with assistance.

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.
• Experience or familiarity with computer systems such as Delta, PCR, POMS, LIMS, and SAP.

Responsibilities

• Follow work instructions, production specifications, and SOPs to perform manufacturing responsibilities, 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 interfacing, integrity testing, and in-process testing such as pH, conductivity, and spectroscopy.
• Handle and discard hazardous materials in accordance with 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 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