Manufacturing Associate II - 3rd Shift

Essential Duties & Responsibilities

• Follow work instructions, production specifications, and standard operating procedures (SOPs) to perform key responsibilities and maintain quality data while meeting production goals and timelines and minimizing downtime/delays.
• Weighing and dispensing of materials.
• Media and buffer preparation.
• Operation of filtration systems (such as 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, and Spectroscopy).
• Properly handle and discard hazardous materials (i.e, buffers, chemicals, etc.) in accordance with EHS guidelines.
• Remove used and soiled materials from manufacturing areas.
• Follow daily and weekly cleaning routines for cleanrooms and equipment to maintain the required conditions for cleanroom manufacturing.
• Track, request, stage and verify raw materials and commodities; accurately enter raw material and commodities data in MES on daily basis.
• Completes Batch Records and other cGMP documentation accurately and in a timely manner in compliance with good documentation practices, including but not limited to ALCOA++.
• Revision of solution preparation batch records, SOPs, protocols, and logbooks.
• Provides support during quality audits and regulatory inspections.
• Reports nonconformances or events that arise during the shift to the Supervisor.
• Complies with all safety, cGMP and Company policies, practices and procedures.
• Performs other functions as required or assigned.

Qualifications

Education and Experience: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred OR high school diploma and at least 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 fast-paced environment and handle manufacturing demands and priorities.
• Excellent interpersonal skills, 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 of the equipment and manufacturing processes.
• Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.
• Basic computer skills, including Microsoft Word, Excel, and PowerPoint.
• Operation and understanding of data management software.
• Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.
• 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, etc.

Working Environment / Physical Requirements

• Must be able to move around the facility to reach various equipment.
• Physical lifting and shift required for pushing and pulling containers. 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.
• Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching. Frequent repetitive motions.
• Manufacturing shift hours: Shift B (first shift): 9:00 AM to 5:30 PM CST (first 14 days), Shift D (third shift): 10:00 PM to 6:30 AM CST. Overtime (time-and-a-half pay), holidays, and weekends will be required based on process requirements.