MSAT Specialist

2 weeks ago

Philadelphia, Pennsylvania, United States Planet Pharma Full time
Job Title: MSAT Specialist

Job Summary:

The MSAT Specialist is a key member of our manufacturing operations team, responsible for ensuring the highest quality standards in our cell therapy manufacturing processes. This role requires a strong understanding of GMP systems, cell culture, and aseptic technique, as well as excellent analytical and problem-solving skills.

Key Responsibilities:

  • Serve as a technical SME for manufacturing processes, representing MSAT in cross-functional meetings and providing expert guidance on process development and implementation.
  • Perform Person-In-Plant (PIP) responsibilities at CMOs, observing production and providing real-time feedback and support during execution of cell therapy batches.
  • Provide MSAT oversight, training, and support within the manufacturing cleanroom environment, ensuring alignment of manufacturing practices across multiple facilities.
  • Execute Technology Transfer responsibilities related to new product introduction or process improvements, providing hands-on manufacturing process training to manufacturing personnel as needed.
  • Author and manage documentation, including Quality Systems, minor study or investigational protocols, and process characterization, validation, and qualification protocols.

Requirements:

  • B.S. degree in a relevant discipline or equivalent industry experience.
  • Minimum of 1 year of relevant hands-on operations experience in clinical or commercial production and/or process development in the life sciences industry.
  • Expertise in cell culture and aseptic technique.
  • Knowledge and understanding of GMP systems within a manufacturing facility.
  • Ability to organize and analyze manufacturing process data.
  • Knowledge of manufacturing process tech transfer.
  • Excellent oral and written communication skills, with strong technical writing ability.

Preferred Qualifications:

  • Prior cell therapy experience is highly preferred.
  • Involvement in prior manufacturing process tech transfer is preferred.

Work Environment:

This position will work in both an office and a laboratory setting, with potential exposure to hazardous or biological waste within the environment. The successful candidate will be able to work in a fast-paced small company environment and adjust their workload based on changing priorities.

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