Manufacturing Associate I (DS) 3rd shift

Kashiv BioSciences, LLC•Chicago, IL

3h•$26 - $30•Onsite

About The Position

The Manufacturing Associate I (DS) is a regular employee in a full-time non-exempt position at Kashiv BioSciences, 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 BioSciences policies, procedures (SOPs), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.

Requirements

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.
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.
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.

Nice To Haves

Associate degree or higher in Biology, Chemistry, Biotechnology, or related preferred
Aseptic techniques and cleanroom manufacturing experience are preferred.

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 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