Manufacturing Associate III (DS)

Description

The Manufacturing Associate III (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). 
• Routinely train other employees and delegate tasks to employees, in absence of supervision. 
• Performs 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. Performs routine inventory counts and inventory adjustments. 
• Complete Batch Records and other cGMP documentation accurately and in a timely manner. May assist with documentation, such as Change Control, CAPA, and Deviation / Investigation. 
• Perform routine documentation checks and reviews for completeness and accuracy. Requests routine documentation. 
• Report nonconformances or events that arise during the shift to the Supervisor. Gathers requested evidence for nonconformances or events that arise during the shift. 
• Communicates processing and sampling times to supporting departments and stakeholders in absence of floor supervision. 
• Interact between shifts to gain and pass along information to facilities a smooth transition between shifts without operation interruption. 
• Assists in the transfer of technology from Process Development to cGMP Manufacturing. 
• Consistently look for improvements and efficiencies to reduce waste and increase production within established quality standards. 
• 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 5 – 10 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.

Work Environment & Physical Demands:

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. 

Standing – Frequently

Stooping – Occasionally

Bending – Occasionally

Lifting up to 40 lbs. - occasionally

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.