Biotechnology Specialist

2 months ago


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

Planet Pharma is seeking a highly skilled and detail-oriented Biotechnology Specialist to join our team in the Aseptic Manufacturing Department. As a Biotechnology Specialist, you will play a critical role in the development and production of cell-based therapies.

Key Responsibilities
  • Develop and execute GMP cell therapy manufacturing processes, ensuring compliance with regulatory requirements and company standards.
  • Complete training sessions and maintain accurate training documentation.
  • Understand and adhere to quality standards, including Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
  • Provide operational support functions, including materials management, kit preparation, and equipment maintenance.
  • Review and maintain accurate documentation, including Batch Records and Logbooks.
  • Collaborate with cross-functional teams to ensure seamless execution of manufacturing processes.
  • Participate in daily huddle meetings and escalate issues to Area Management for further investigation.
  • Work independently and as part of a team to achieve manufacturing goals and objectives.
  • Adhere to company policies, procedures, and core values.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures.
  • Perform miscellaneous duties as assigned.
Requirements
  • Bachelor's degree or equivalent in a life science or related field.
  • Minimum 0-1 years of experience in biopharmaceutical-based GMP manufacturing operations, including cell culture and downstream processing.
  • Strong analytical and problem-solving skills, with ability to work in a fast-paced environment.
  • Excellent communication and teamwork skills, with ability to build relationships quickly and credibly.
  • Proficient in Microsoft Office, including Excel, Word, and Outlook.
  • Ability to read, write, and understand English for Good Documentation Practices.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.


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