Manufacturing Associate

1 week ago


San Diego, California, United States TANVEX BIOPHARMA USA INC Full time
Job Summary

We are seeking a highly skilled Manufacturing Associate - Downstream Operations to join our team at Tanvex Biopharma USA Inc. The successful candidate will be responsible for performing routine manufacturing activities in GMP manufacturing areas, including purification and associated sub-processes/preparation.

Key Responsibilities
  • Perform GMP manufacturing activities in assigned areas, adhering to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and plant safety guidelines.
  • Set up, operate, maintain, and clean downstream bioprocessing equipment, including chromatography systems, UF/DF, and viral filtration skids and mixers.
  • Demonstrate good aseptic technique and basic troubleshooting of bioprocess equipment.
  • Perform manual cleaning and sterilization of manufacturing areas, parts, and components.
  • Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records, following manufacturing Good Documentation Practices (GDP).
  • Draft and revise SOPs and batch records.
  • Initiate quality events - DEVs, IRs, and OOTs.
  • Participate in regularly scheduled team meetings to discuss ideas, troubleshoot issues, and identify future projects or tasks.
Requirements
  • Bachelor's or advanced degree in life sciences or a related discipline, or equivalent education and experience.
  • Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
Preferred Qualifications
  • cGMP for biological products preferred.
  • Strong preference for Downstream/Purification experience and skills in Protein Chromatography, TFF, Depth Filtration, Viral Filtration, Bulk Drug Substance Formulation, and Final Filtration.
  • Familiarity with Unicorn and Common Control Platform (CCP) Software is preferred.
  • Fundamental knowledge of current biologics regulations and cGMP for drug substance operation.
  • Proficient with Microsoft Word and Excel.
  • Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.


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