Manufacturing Associate Cell therapy level 1 Nights

United States, Portsmouth (New Hampshire)

The Manufacturing Associate, Level I, will help to provide a safe, controlled work environment in all areas of expertise. Be aware of the site safety objectives and make sure they are communicated and understood. Manufacturing Associate, Level I, will work to be proficient in an assigned area and work in a team environment during manufacturing operations (i.e. harvest, fill/finish, visual inspection, etc.).  Work with Technical Transfer SMEs to transfer in and maintain customers' processes in production facility.  Become proficient in assigned trainings related to any new equipment or systems to be used in Cell Therapy. Work to develop documentation and trainings on any new equipment to be used in Cell Therapy. Collaborate with CT Manufacturing team to incorporate process and operational improvements into new customer processes in manufacturing.  Collaborate with CT Manufacturing team to determine equipment and materials the suite will need to purchase in order to run the process

Support the definition and execution of Operational Readiness Activity for the Cell Therapy Site projects at LPO to include:

  • Set up of manufacturing procedures & collaboration with QA to support CT quality systems aligned with existing operations.
  • Support building & establishing the manufacturing team by participating in the training of new colleagues.
  • Complete the appropriate Safety, Gowning, Material Movement, Visual Inspection, APS, Cleaning, Scheduling, and EM Trainings.
  • Support the definition and execution of all activity in compliance with EHS requirements.
  • Manufacturing readiness to include staying up to date with training, compliance wire, icomply, and other relevant assignments
  • Cleaning of manufacturing spaces and ensuring manufacturing space is ready for use

Support the definition and execution of Technical Transfer activities for the CT projects at LPO to include:

  • Operational input into executing manufacturing activity related to Technical Transfer – water runs, training runs, particle runs, engineering runs etc.
  • Work to complete timely delivery of milestones for the Technical Transfer schedule.
  • Author, review, and approve documentation (Batch Records, SOPs, WIs, LQMs, PMs and logbooks) for completeness, clarity, accuracy, and submit edits for revision as required.
  • Learning process flow, theory and implementation strategy of customer processes that are being transferred to the LPO CT facility.
  • Attend customer site visits, collect data and process information to be incorporated into LPO site processes

As project contributor collaborate with CT Manufacturing Leadership Team to ensure:

  • Timely updating of relevant project metrics
  • Appropriate interaction with assigned internal stakeholders (i.e. MSAT, QA, QC, etc.).
  • Perform other duties as assigned.
Reference: R36802