Manufacturing Supervisor (DS) 3rd Shift

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Job Type

Full-time, Contract

Description

The Manufacturing Supervisor (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 executing and facilitating the manufacturing of Biotechnology products for clinical and commercial human use. This employee will have shift accountability for the drug substance production lines. This employee applies aseptic techniques while working in controlled and classified environments, which require cleanroom gowning and some aseptic gowning. Employee oversees reports to complete manufacturing in accordance with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

Essential Duties & Responsibilities

• Execute and effectively delegate 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 adjust controls and interacts with HMI interfacing to ensure smooth operation of equipment. Performs diagnosis and troubleshooting for equipment and manufacturing processes.
• Must possess the ability to multitask; problem-solve; formulate action plans based on real data and experience. Must thrive in fast-paced, team environment.
• Ability to train diverse team members. Ensure employee training is current and the training meets the required standards of the job.
• Drive engagement by building rapport, having routine 1 : 1, developing goals, conducting performance reviews, and arranging opportunities for growth. Provide coaching, counseling, development, discipline and recognition of direct staff. Approve timecards, manage attendance.
• Create an environment where safety is a priority, for example, through enforcement of proper PPE; proper handling and discarding of hazardous materials buffers, chemicals, etc.) in accordance with EHS guidelines; removing used and soiled materials from manufacturing areas.
• Effective coordination of activities within the shift as well as smooth transition of tasks to the next shift. Communicate processing and sampling times to departments and stakeholders.
• Follow daily and weekly cleaning routines for cleanrooms and equipment to maintain the required conditions for cleanroom manufacturing. Perform routine checks of manufacturing areas and coordinates with appropriate personnel for resolution.
• Verify raw materials and commodities; accurately enter raw material and commodities data in MES on daily basis. Performs routine inventory counts and inventory adjustments. Request raw materials and commodities.
• Complete Batch Records and other cGMP documentation accurately and in a timely manner. Perform daily documentation review and approval. Request routine documentation. Assist with documentation, such as Change Control, CAPA, and Deviation / Investigation.
• Report nonconformances or events that arise during the shift to the Manager. Gather requested evidence for nonconformances or events that arise during the shift.
• Assists in the transfer of technology from Process Development to cGMP Manufacturing. Participate in execution of qualification and validation activities.
• Author and reviews SOPs and other documents to ensure integration of cGMPs and improve process efficiency.
• Performs process monitoring, including use of databases, documents and / or spreadsheets to support business reporting requirements.
• Propose 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 :

Special Skills

Language :

Reasoning Skills :

Computer and / or Technical Skills :