Manufacturing Associate ; DS 3rd shift

Manufacturing Associate I

The Manufacturing Associate I (DS) is a regular employee in a full-time non-exempt position at Kashiv Bio Sciences, LLC, in Chicago, IL. The Manufacturing Associate is a hands-on production position responsible for the manufacturing of biotechnology products for clinical and commercial human use. The employee is responsible for executing upstream fermentation and downstream purification processes for a range of microbial-based biosimilars.

Employee applies aseptic techniques while working in controlled and classified environments, which require cleanroom gowning and some aseptic gowning. Must comply with Kashiv Bio Sciences policies, procedures (SOPs), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.

Essential duties and responsibilities include:

• 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 clean rooms 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 a 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

Position requirements and qualifications:

Education and experience:

• 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 are 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. The schedule is driven by process requirements. The need for support of manufacturing activities may run through weekends or outside of normal shift hours.

• Excellent interpersonal skills, effective communication with peers and supervision.

• Reasoning skills

o The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.

o Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes

o Ability to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.

Computer and/or technical skills:

o Basic computer skills, including Microsoft Word, Excel, and Power Point

o Operation and understanding of data management software

o Skills for working with computer systems, such as:
Delta, PCR, POMS, LIMS, SAP, etc.

o Knowledge of GMP, GDP and safety requirements.

o 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…