Aseptic Manufacturing Operations Supervisor

6 days ago


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

We are seeking an experienced Aseptic Manufacturing Operations Supervisor to join our team at Planet Pharma. As a key member of our manufacturing operations team, you will be responsible for overseeing the production process, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives.

Key Responsibilities
  • Leadership and Supervision: Provide guidance and oversight to direct reports, mentoring and coaching to motivate and develop staff, fostering a culture of continuous improvement and operational excellence.
  • Process Management: Develop a comprehensive understanding of current production processes, ensuring conformance to daily schedules and regulatory requirements.
  • Quality Assurance: Perform review of batch documentation and logbooks for completeness and accuracy, ensuring compliance with quality standards and requirements.
  • Documentation and Training: Author and revise documentation, including SOPs, batch records, deviations, and CAPAs, as well as providing training and support to staff.
  • Regulatory Compliance: Ensure efficient operations and compliance with cGMPs and safety regulations, staying up-to-date with current Good Manufacturing Practices (cGMP) guidelines.
Requirements
  • Education: Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry and technical experience.
  • Experience: Minimum of 5 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture.
  • Skills and Knowledge: Demonstrated technical knowledge of aseptic processing in cleanroom environments, strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture processing.
  • Leadership and Communication: Strong oral and written communication skills, ability to mentor and provide best practices to other members of the team, and ability to build relationships quickly.
  • Physical Demands: Ability to wear clean room attire and PPE, stand and/or walk 90% of a 10-hr day, and lift 20 lbs.
Preferred Qualifications
  • Leadership Experience: Minimum of 3+ years in a Lead/Leadership/Supervisory Role.
Work Environment

This position will work in both an office and a manufacturing lab setting, with exposure to biohazards, human blood components, chemicals, and variable noise levels.



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