Manufacturing Associate II

Company: Kashiv Biosciences LLC
Location: Melrose Park
Posted on: May 28, 2023

Job Description:

Description:$2,500 SIGN-ON BONUSThe Manufacturing Associate II, is a regular employee in a full-time non-exempt position at Kashiv Biologics, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.Essential Duties & Responsibilities

• Will be assigned to the daily operations, working with:
• Weighing and dispensing of material
• Filtration systems
• Inoculation of mammalian or cytokines cells
• Fermentation and harvest
• Chromatography columns and TFF operations
• Responsible for in-process testing, such as: pH, Conductivity, Spectrophotometer, Osmometer, Cell count, etc.
• Prepares media and buffer solutions.
• Completes Batch Records and other cGMP documentation accurately and in a timely manner.
• Remove and dispose soiled materials from the manufacturing area.
• Will assure that the manufacturing areas are maintained within the required conditions for clean room manufacturing.
• Will report all nonconformance or events that arise during the shift to the Supervisor.
• Assists in the transfer of technology from Process Development to cGMP Manufacturing.
• Complies with all safety, cGMP and Company policies, practices and procedures.
• Performs other functions as required or assigned
• Complies with all company policies and standardsRequirements:Education:
  • Associate degree or higher in Biology, Chemistry, Biotechnology or related preferred
  • An equivalent of 2 4 years of biologics industry experience requiredSpecial SkillsLanguage:
    • 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.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:
        • 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, Fermentation Process, Inoculation Process, Chromatography Columns, TFF step 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. Some travel may be involved.Supervisory Responsibility, if any: NoBenefits/Perks:
          • $2,500 Sign-on bonus
          • Medical
          • Dental
          • Vision
          • 401K
          • FSA - Commuter/Transit
          • Student Loan Assistance
          • Monthly Cell Phone Allowance
          • Free Parking (Company Paid)
          • On-site Gym
          • Conveniently located next to the Metra, Green and Red Line
          • One block east of the Chicago White Sox Stadium
          • 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.Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.PI216061985

Keywords: Kashiv Biosciences LLC, Chicago , Manufacturing Associate II, Other , Melrose Park, Illinois