Manufacturing Operations Specialist

3 weeks ago


San Mateo, California, United States Fladger Assoc. Inc. Full time
Job Description

Fladger Assoc. Inc. is seeking a highly skilled Manufacturing Technician to join our team in Oceanside, CA. As a key member of our manufacturing operations team, you will be responsible for the safe and efficient operation of large- and small-scale chromatography columns and skids, viral filtration and ultrafiltration/diafiltration skids, as well as all related equipment and systems.

Key Responsibilities:
  • Operate and maintain chromatography columns, skids, and related equipment to support clinical manufacturing operations.
  • Ensure compliance with cGMP regulations and SOPs, and accurately complete documentation associated with clinical manufacturing.
  • Collaborate with the team to plan and execute the safe and efficient operation of assigned processes, and communicate any issues or concerns to the team lead.
  • Participate in the planning and execution of all operations associated with weigh, dispense, and buffer preparation, protein purification, and clean in place (CIP) and steam in place (SIP) of fixed tanks/vessels and portable equipment.
  • Develop and maintain proficiency in analytical equipment, including pH/conductivity meters and osmometers.
  • Work under demanding production schedules and strict compliance/quality requirements, and coordinate with support groups to ensure seamless operations.
Requirements:
  • Minimum 3 years of relevant experience in a biologics cGMP related industry.
  • High school diploma or equivalent required; bachelor's degree in biology or related scientific discipline preferred.
  • Excellent communication and problem-solving skills, with the ability to work independently and in teams.
  • Flexibility to work day, swing, or night shifts, and/or weekends.


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