Supervisor, Aseptic Processing

4 weeks ago

Philadelphia, United States Planet Pharma Full time

*2ND SHIFT 5:00pm-3:00am*


Overview


The Supervisor, Aseptic Processing is a part of the Manufacturing team. The critical raw material is processed from leukapheresis units and frozen. This role provides guidance and oversight to the process and production as well as timely document review, ensuring material is made in a safe and compliant manner and meeting company targets. The Aseptic Manufacturing Supervisor is also responsible for the development of staff, ensuring a highly effective "First time right" program, to accommodate Iovance's needs as a growing organization. This role provides support the management of any deviations and CAPAs for manufacturing team. The supervisor demonstrates innovative technical knowledge and will significantly contribute to the overall manufacturing operation.

As this role is part of the leadership team for manufacturing operations, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is required.


Essential Functions and Responsibilities

  • Supervision and Development of direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
  • Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule.
  • Develop a comprehensive understanding of current production process, as this role is viewed as a subject matter expert within specific area. Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required.
  • Perform review of batch documentation and logbooks for completeness and accuracy.
  • Ability to work under limited supervision and to handle problems of a more difficult nature.
  • Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of the operation.
  • Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
  • Author and revise documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
  • Ensure the department understands and complies with quality standards and requirements as documented.
  • Ensure efficient operations, and compliance with cGMPs and safety regulation.

Required Education, Skills, and Knowledge

  • Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry and technical experience.
  • Minimum of 5 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture
  • Demonstrated technical knowledge of aseptic processing in cleanroom environments a must.
  • Strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture processing.
  • Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation (batch records, deviations, ). Strong technical writing ability required.
  • Experience leading “development” initiatives, e., training, coaching, learning initiatives.
  • Ability to mentor and provide best practices to other members of the team.
  • Ability to build relationships quickly and Provide consistent, excellent support to entire staff, with the ability to manage the teams within the manufacturing environment.
  • Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
  • Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
  • Ability to work successfully in a fast-paced team-oriented environment.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues.


Preferred Education, Skills, and Knowledge

  • Minimum of 3+ years in a Lead/Leadership/Supervisory Role is desire

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