Job Description

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