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Bioprocessing Associate II

2 months ago

King of Prussia, Pennsylvania, United States SK pharmteco Full time
Job Summary

The Bioprocessing Associate II for Manufacturing will be responsible for the manufacture of Master and Working Cell Banks, Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). The incumbent will be responsible for operating upstream and downstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards.

Key Responsibilities
  • Manufacturing Operations
    • Operate upstream and downstream equipment for adherent and suspension systems.
    • Perform production support activities.
  • Quality Assurance
    • Maintain compliance to cGMP standards.
    • Identify and correct unacceptable practices of aseptic technique.
  • Technical Support
    • Provide technical support to production teams.
    • Participate in tech transfer activities.
  • Documentation and Training
    • Author and revise SOPs.
    • Train others on basic SOPs, equipment, and unit operations.
Requirements
  • Education
    • High School Diploma or Associate's degree with 3+ years of experience, or Bachelor's degree (science preferred) with 1+ years of experience.
  • Skills and Experience
    • Working knowledge of cGMP regulations.
    • Experience working in a Biological Safety Cabinet (BSC).
    • Effective written and verbal communication skills, with excellent teamwork aptitudes.
  • Preferred Qualifications
    • Experience working with incubators, pipettes, single-use bioreactors, aseptic operations, cell culture, seed scale-up, single-use chromatography and UF/DF systems, and ultracentrifuges.
    • Working knowledge of cell expansion vessels such as T-flasks or shake flasks and viral vector purification methods for gene therapy products.
Physical Requirements
  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.