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Bioprocessing Associate II

2 months ago

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

We are seeking a highly motivated and detail-oriented Bioprocessing Associate II to join our Manufacturing team at SK pharmteco. As a key member of our team, you 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).

Key Responsibilities
  • Operate upstream and downstream equipment for adherent and suspension systems, ensuring compliance to cGMP standards.
  • Perform production support activities, including basic troubleshooting and equipment maintenance.
  • Participate in tech transfer activities and assist with validation execution.
  • Received and organize materials, identifying and communicating discrepancies of material deliveries.
  • Use support systems (SAP, Veeva, LIMs, etc.) efficiently.
  • Train others on basic SOPs, equipment, and unit operations.
  • Provide information for technical document authoring.
  • Suggest and participate in continuous improvements.
Requirements
  • H.S/Assoc with 3+ years of experience, or B.S (science preferred) with 1+ years of 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 experience includes 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.
  • Ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows ability to learn and problem-solve.
  • Exhibits technical aptitude to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.
Physical Requirements
  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE daily.