Manufacturing Associate I (DS) -3rd Shift

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 (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.
• Track, request, stage and 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 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.
  

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 is 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 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
• 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
• 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.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:
General Work Environment: GMP Clean rooms and Laboratories
• Must be able to move around the facility to reach various equipment
• Physical lifting and shift required for pushing and pulling containers. Must be able to lift at least 25 lbs. Frequent moving of 25-50 lbs on carts.
• Frequent moving of 100-250 lbs with assistance.
• Must be able to stand for long periods of time
• Handwriting: Manufacturing processes require extensive documentation in accordance with current Good Manufacturing and Good Documentation Practices. Such documentation must be product in a manner that is both neat and legible.

Additional Position Information:
Manufacturing shift hours:

• Shift B (first shift): 9:00 AM to 5:30 PM CST (first 14 days for training),

• Shift D (third shift): 10:00 PM to 6:30 AM CST (Shift Differential available)

Overtime (time-and-a-half pay), holidays, and weekends will be required based on process requirements.

The hourly rate for this position ranges from $25.00 to $30.00 per hour. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.