51 jobs found

Arnold Magnetic Technologies is a leading global manufacturer of high-performance permanent magnets, flexible composites, electromagnets, magnetic assemblies, and precision thin metal foils. Arnold's magnets, metals, and systems are used in high-efficiency electric motors and generators, sensors, batteries, and more. Brief Summary of Position: Perform a variety of duties in the set-up and operation of roll conditioning equipment used to condition a variety of mill rollers and in the set-up and operation of mill rewind and cleaning lines. Responsibilities/Essential Functions of Position: Work from standard processing or verbal instructions. Maintain job and production records. Maintain identity of materials. Assist in other areas of the PTM facility as necessary. Machine Tooling Operator (Lapper) Responsibilities: Set-up manual & automatic lapping machines. Select rotary lap needed to condition mill roll. Place roll into lapper, start machine and move pressure paddle back and forth to remove defects, such as gouges, pin pricks, holes and unparalleled. Use instruments to measure and assure that necessary roll dimensional and surface finish requirements are met. Deburr strip, when required. Maintain identification of materials. Perform any other functions related to the lapping and tool conditioning. Rewind Responsibilities: Set-up and operate foil mill rewind and cleaning lines. Detect and correct operations difficulties. Report unusual operating difficulties to supervisor. Operate rewind and test equipment to perform visual strip inspection for color, holes, streaks, and lamination, magnetic and other defects. Keep work area in a clean an orderly condition. Required Technical/Job Experience and Qualifications: 1-3 years in a manufacturing environment Basic math skills (add, subtract, multiply and divide) using decimals and fractions. Strong communication skills to facilitate productive and consistent handling of material Education Requirements: High School degree, diploma or a GED equivalent qualification from a certified college. Working Conditions: Standard work week is Monday through Friday, hours to be consistent with business unit; some off hours work expected Working production environment Physical Requirements: Must be able to lift a minimum of 25 - 40 pounds Occasionally, must use hand-trucks Standing for extended periods of time Machines/Equipment Used: Variety of hand tools. Lapping machines Micrometers, microscopes 2nd Shift Hours: 3:30PM - 11:30AM 3rd Shift Hours: 11:30PM - 7:30AM Arnold Magnetic Technologies is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Minority/Female/Sexual Orientation/General Identity/Disability/Veteran PI7f806d1069b2-7936

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate II (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Perform work instructions with minimal supervision. Work instructions include but are not limited to: 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). Train other employees when requested or required to do so. Has the ability to perform troubleshooting for equipment and manufacturing processes. 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. 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. Performs routine documentation checks and reviews for completeness and accuracy. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 2 4 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers, supervision, and supporting departments. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI685db8fd3b63-5457

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456

Description: The Manufacturing Associate I (DS), is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. 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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. 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. Work instructions include but are not limited to: 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. 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. 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 Requirements: Education: Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred Or an equivalent of 0 2 years of industry experience required Aseptic techniques and cleanroom manufacturing experience is preferred. Special Skills Language: Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English. Excellent interpersonal skills, effective communication with peers and supervision. Reasoning Skills: The candidate should have the 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. Computer and/or Technical Skills: Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc. Operation and understanding of word processing, spreadsheets, and data management Knowledge of GMP 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. PI41da023b5ea7-5456