Aseptic Manufacturing Specialist

4 days ago


Philadelphia, Pennsylvania, United States Planet Pharma Full time
About the Role

The Aseptic Manufacturing Technician I position at Planet Pharma is a critical role in our autologous cell therapy manufacturing program. This position requires a comprehensive understanding of theories, techniques, and principles to support manufacturing processes.

Key Responsibilities
  • Manufacturing Process Execution: Develop a thorough understanding of and execute GMP cell therapy manufacturing processes with proficiency.
  • Training and Documentation: Complete training sessions and maintain accurate training documentation.
  • Quality Compliance: Understand and adhere to quality standards and requirements as documented.
  • Operational Support: Provide support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
  • Document Review: Perform document review, including executed Batch Records and Logbooks.
  • Regulatory Compliance: Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP), and complete recording of data to comply with regulatory requirements.
  • Team Collaboration: Attend daily huddle meetings and escalate issues/concerns to Area Management for further investigation.
  • Adaptability: Demonstrate ability to work in a team environment and independently as required, recognizing deviations from accepted practices.
  • Core Values: Adhere to core values, policies, procedures, and business ethics.
  • Safety Protocols: Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Miscellaneous Duties: Perform miscellaneous duties as assigned.
Requirements
  • Education: Bachelor's degree or some post-secondary education.
  • Experience: Minimum 0-1 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
  • Skills: Proficient in Microsoft (Excel, Word, Outlook), ability to perform arithmetic calculations, and quality mindset.
  • Knowledge: Familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Personal Qualities: Proactive, results-oriented, self-starter with experience in a complex manufacturing environment, ability to build relationships quickly and credibly, and ability to work successfully in a fast-paced, team-oriented environment.


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