Ts/ms Primary Loop (r4)

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN

Eli Lilly is seeking a TS/MS Primary Loop (R4) to act as a process expert for external manufacturing, focusing on pre-filled syringes, autoinjectors, and packaging. The role involves owning the process control strategy, ensuring validated states, managing deviations, and driving continuous improvement. Requires a Bachelor's degree in a relevant field and 5 years of experience in pharmaceutical manufacturing, cGMPs, validation, deviation resolution, device assembly/packaging, and technology transfer.

What you'd actually do

  1. Act as the process expert with regards to the process steps or processing equipment (pre-filled syringes autoinjectors and packaging), owning the process control strategy including the key process parameters, critical quality attributes, and the historic and potential failure modes of the process.
  2. Ensure that the process is maintained in a validated/controlled/capable state, participating in the strategy design and execution process, for post commercialization validation process.
  3. Provide support to management of daily operations by owning process-related deviations, complaints, corrective and preventative actions, and changes.
  4. Own the process capability and yield variables and identify opportunities for improvement.
  5. Build and maintain relationships with external manufacturers.

Skills

Required

  • Bachelor’s degree in Pharmacy, Chemistry, Manufacturing Engineering, or a related field
  • 5 years of experience with pharmaceutical manufacturing and technical services
  • 5 years of experience with cGMPs and drug product manufacturing
  • 5 years of experience completing qualification and validation activities
  • 5 years of experience with deviation resolution and continuous improvement change planning and implementation for pharmaceutical manufacturing
  • 5 years of experience providing support for device assembly and packaging
  • 5 years of experience with technology transfer between packaging lines or manufacturing facilities

What the JD emphasized

  • cGMPs and drug product manufacturing
  • qualification and validation activities
  • deviation resolution and continuous improvement change planning and implementation for pharmaceutical manufacturing
  • technology transfer