Manufacturing Associate I (DS) - 3rd Shift

Essential Duties & Responsibilities

• Follow work instructions, production specifications, and SOPs to perform key responsibilities and maintain quality data while meeting production goals and timelines.
• Weighing and dispensing of materials.
• Media and buffer preparation.
• Operation of filtration systems (dead-end filtration, depth filtration, tangential flow filtration).
• Inoculation, fermentation, harvest, and homogenization of cytokine cells.
• Setup and operation of chromatography columns.
• Aseptic final filtration of intermediates and drug substances.
• Monitor product for quality output using PLC controls, HMI interfacing, integrity testing, and in-process testing (pH, conductivity, spectroscopy).
• Properly handle and discard hazardous materials in accordance with EHS guidelines.
• Follow daily and weekly cleaning routines for cleanrooms and equipment.
• Track, request, stage and verify raw materials and commodities; enter data in MES daily.
• Complete Batch Records and other cGMP documentation accurately and timely per good documentation practices (ALCOA++).
• Revise solution preparation batch records, SOPs, protocols, and logbooks.
• Provide support during quality audits and regulatory inspections.
• Report nonconformances or events to the Supervisor.
• Comply with all safety, cGMP and company policies, practices and procedures.

Qualifications

Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred OR high school diploma and 1-2 years of industry experience required. Aseptic techniques and cleanroom manufacturing experience is preferred.

Knowledge, Skills, Abilities

• Ability to understand and adhere to written and verbal instructions.
• Ability to understand technical information, procedures, batch records, and other documents in English.
• Ability to learn properly and efficiently using various hand and electrical tools.
• Ability to work in a fast-paced environment and handle manufacturing demands and priorities.
• Excellent interpersonal skills and effective communication with peers and supervision.
• Ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.
• Basic skills for identifying problems and troubleshooting equipment and manufacturing processes.
• Ability to work independently or as a team member and follow detailed directions.
• Basic computer skills including Microsoft Word, Excel, and PowerPoint.
• Operation and understanding of data management software.
• Skills with computer systems such as Delta, PCR, POMS, LIMS, SAP.
• Knowledge of GMP, GDP and safety requirements.
• Knowledge of biotechnology operations such as aseptic filtration systems, aseptic sampling, filter integrity testing, fermentation process, inoculation process, chromatography columns, mixing systems, weigh scales.

Working Environment / Physical Requirements

• GMP clean rooms and laboratories.
• Must be able to move around the facility to reach various equipment.
• Must be able to lift at least 25 lbs; frequent moving of 25-50 lbs on carts; frequent moving of 100-250 lbs with assistance.
• Must be able to stand for long periods of time.
• Extensive documentation requiring neat and legible handwriting.

Additional Position Information

Manufacturing shift hours: Shift B (first shift) 9:00 AM to 5:30 PM CST (first 14 days for training), Shift D (third shift) 10:00 PM to 6:30 AM CST (shift differential available). Overtime, holidays, and weekends will be required based on process requirements.