Manufacturing Technician

Experience with aseptic gowning procedures, cleanroom behavior, and aseptic technique when handling all product-contact components.

Experience with TFF, UF, or Diafiltration, either at the bench scale or large scale.

Experience with large scale buffer, media or solution preparation, encompassing weigh & dispense, buffer preparation, transfer and aseptic filtration.

Experience reviewing standard operating procedures, batch records, GMP Logbooks

Experience working in GMP manufacturing within a late-stage clinical or commercial environment.

Experience working with process automation, electronic batch record and process skid PLC programming.

Experience working in aseptic fill/finish, filling isolators.

Experience working with single use manufacturing consumables such as bags, tube sets, bioreactors, columns and process manifolds.

Experience authoring standard operating procedures, batch records and working in GMP document generation/life cycle management.

Experience working towards the qualification of aseptic manufacturing processes in preparation for late-stage clinical and commercial phases/launch.