Manufacturing Associate II (DP)

Amneal India • Chicago, IL

14h • $30 - $35 • Onsite

About The Position

The Manufacturing Associate II is a regular, full-time, non-exempt position at Kashiv BioSciences, LLC, in Chicago, Illinois. The employee manufactures biotechnology products for clinical and commercial human use, working with aseptic techniques in controlled and classified environments, some of which require complete aseptic gowning. The role requires compliance with company policies and procedures, FDA current Good Manufacturing Practices (cGMP), and other applicable government requirements.

The position performs manufacturing activities including line inspection and clearance, materials weighing and dispensing, equipment operation and calibration, formulation, filtration, and aseptic filling. The associate maintains clean-room conditions and inventory, verifies materials, prepares media and buffer solutions, submits samples for in-process testing, completes batch records and other documentation, and reports nonconformances or events to the Supervisor. The role also supports technology transfer from Process Development to cGMP Manufacturing and may perform packaging or other assigned functions.

The work takes place in GMP clean rooms and laboratories. The position requires extended standing, facility movement, lifting and moving containers, repetitive motions, occasional bending and related physical activity, and extensive neat and legible documentation. Various manufacturing shifts are available; overtime, holidays, and weekends are required based on process requirements. The hourly pay range is $30.00–$35.00, with overtime eligibility, applicable evening shift differentials, and a short-term incentive opportunity such as a bonus or performance-based award within the first 12 months. Eligible employees can choose from health and insurance benefits and receive a significant 401(k) matching contribution, along with well-being programs.

Requirements

• An associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field is preferred; alternatively, 1–4 years of industry experience is required.
• Basic verbal and written English communication skills, including the ability to understand technical information, procedures, batch records, and other documents.
• Excellent interpersonal skills.
• Ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
• Basic ability to identify problems and troubleshoot equipment and manufacturing processes.
• Ability to work independently within SOPs and prescribed guidelines, work as a team member, and follow detailed directions.
• Computer skills using systems such as POMS, LIMS, SAP, or NetSuite.
• Ability to use word processing, spreadsheets, and data-management tools.
• Knowledge of GMP and safety requirements.
• Ability to lift at least 25 pounds; frequently move 25–50 pounds on carts and, with assistance, frequently move 100–250 pounds.
• Ability to stand for long periods, move around the facility to reach equipment, and perform occasional bending, squatting, kneeling, stooping, pushing, pulling, and reaching, as well as frequent repetitive motions.
• Ability to produce neat and legible manufacturing documentation in accordance with current Good Manufacturing and Good Documentation Practices.
• Availability to work overtime, holidays, and weekends as required by process requirements.

Nice To Haves

• Experience operating autoclaves and filling machines.
• Experience with aseptic techniques and clean-room manufacturing.
• Knowledge of biotechnology operations, including aseptic filtration systems, aseptic sampling, filter integrity testing, stirrer plates, floor scales, peristaltic pumps, and weighing scales.
• Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or a related field.

Responsibilities

• Perform line inspections and line clearance in ISO 6, ISO 7, and ISO 8 areas.
• Weigh and dispense materials.
• Operate part washers, autoclaves, filters, and mixing systems.
• Operate syringe fillers and perform non-viable particle counts.
• Calibrate and verify pH meters, conductivity meters, and weighing scales.
• Standardize and operate peristaltic pumps.
• Perform filter integrity testing.
• Participate in drug product formulation and filtration.
• Participate in aseptic filling while maintaining appropriate aseptic-area behavior.
• Clean ISO 5 and ISO 6 areas according to SOPs.
• Maintain inventory of disinfectant solutions, gowns, goggles, wipes, and other supplies.
• Verify raw materials and other consumables.
• Assemble, clean, sterilize, and operate equipment.
• Prepare media and buffer solutions.
• Submit samples and perform in-process testing, including pH, conductivity, and personnel monitoring plates.
• Submit documents and material requests to the appropriate department to start batch manufacturing operations.
• Electronically record process steps when required.
• Complete batch records and other cGMP documentation accurately and on time.
• Remove and dispose of soiled or expired materials from the manufacturing area.
• Maintain manufacturing areas within the conditions required for clean-room manufacturing.
• Report nonconformances and events arising during the shift to the Supervisor.
• Assist with technology transfer from Process Development to cGMP Manufacturing.
• Comply with safety, cGMP, company policies, practices, procedures, and standards.
• Perform packaging and other functions as required or assigned.

Benefits

• Hourly pay of $30.00–$35.00, with overtime eligibility and applicable evening shift differentials.
• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Comprehensive, flexible health and insurance benefits for eligible positions.
• Significant 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

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