Jobs In Chicago

Manufacturing Associate II

Job Details

Hiring Organization Kashiv BioSciences
Post Name Manufacturing Associate II
Qualification Associate degree or higher in Biology, Chemistry, Biotechnology, or related (preferred but not required)
Industry Private
Employment Type Full Time
Work Hours 8 Hours
Salary USD 30 To USD 35 Per Hour
Location Chicago, Illinois, United States 60616

Description

The Associate II, Manufacturing Operations is a contract employee in a full-time non-exempt position at Kashiv Biosciences, LLC, in Chicago, IL. This employee will be responsible for the aseptic manufacturing of Drug Products, visual inspection, and Secondary Packaging for clinical and commercial products for human use.

Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Kashiv 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
  • Glasswasher and autoclave
  • Media and buffer preparation
  • Filtration systems
  • Aseptic filling of glass vials and pre-fillable syringes.
  • Visual inspection of glass vials and prefilled syringes
  • Responsible for in-process testing, such as pH, Conductivity, etc.
  • Will verify all raw materials and commodities.
  • Responsible for equipment assembly, cleaning, sterilization, and operation.
  • Completes Batch Records and other cGMP documentation accurately and in a timely manner.
  • Removes and disposes of soiled materials from the manufacturing area.
  • Will assure that the manufacturing areas are maintained within the required conditions for cleanroom 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.
  • Writes, reviews, and makes recommendations for change to cGMP documentation such as SOPs and Batch Records.
  • Assists with new employees’ training.
  • Supports coordination of activities as necessary
  • Performs other functions as required or assigned
  • Complies with all company policies and standards

Requirements

Education and experience:

  • Associate degree or higher in Biology, Chemistry, Biotechnology, or related (preferred but not required)
  • Or an equivalent of 2 + years of industry experience required
  • Aseptic techniques and cleanroom manufacturing experience are 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.

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 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, Osmometer, 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. Some travel may be involved.

Apply Now

Leave a Comment