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This position is part of the Bioprocess Research & Development (BR&D) organization and supports the K360 clinical trial pilot plant (CTPP). There are four primary operational areas within K360. Examples of the activities associated with each area are listed below:
Makeup
Make buffers and media from various raw materials.
Perform in-process tests of media and buffers
Clean equipment with clean-in-place cycles and in cabinet washers
Fill media and buffer into process containers
Inoculation Lab
Develop inoculum for microbial and mammalian culture products
Perform bioburden testing for the bioreactors and media operations
Submit samples to third-parties for further evaluation.
Cell Culture/Primary Recovery
Transfer inoculum from the inoculation lab to the bioreactors/fermenters
Monitor, feed, and harvest feed cell culture
Clean equipment with clean-in-place cycles and in cabinet washers
Steam equipment with steam-in-place cycles
Purification
Receive buffers from the makeup area
Purify harvested material with various purification techniques (chromatography, viral filtration, tangential flow filtration, etc.).
Fill the final active pharmaceutical ingredient (API) into storage containers
Clean equipment with clean-in-place cycles and in cabinet washers
Responsibilities:
Technical Ability: The Operator must be able to operate and monitor process equipment and related systems in accordance with approved tickets and procedures. In addition, he/she must be willing to accept new assignments, projects, and challenges as assigned by supervision, be capable of troubleshooting issues as they occur, and identify trends and ways to reduce process variability.
Data Management/Compliance: The Operator must exhibit a high level of attention to detail and a quality-minded approach to all record keeping. Accurate and legible records must be maintained and analyzed to provide detailed information on the status of their operations. All documentation must comply with cGMP practices as defined by Corporate, Divisional, and Local procedures/tickets, policies and practices.
Communication Skills, Oral and Written: This position may require interaction with, but not limited to; Quality Team members, Bioproduct Research and Development scientists, Analytical Services, Operations, Technical Services Representatives, Engineering, and Maintenance personnel. In addition, the Operator must be able to effectively communicate and understand technical information with regards to his/her area.
Safety and Environmental Awareness: The Operator shall be expected to adhere to all safety and environmental guidelines and to promote safety and environmental compliance in all areas.
Basic Requirements:
2+ years' experience relevant to their area (makeup, inoc, MCC, purification, etc.) or 2-year degree in biotechnology
Strong cGMP background: specific experience required in a regulated environment where both quality and safety regulations are being addressed on a daily basis
Experience executing manufacturing tickets, following procedures and completing engineering protocols including the use of Word and Excel.
Ability to interact and build effective relationships with a wide range of groups including: HSE, Quality Control, Tech Services, Development Scientists, Operations, Validation (C&Q), Automation, Engineering, Maintenance, and Environmental Monitoring.
Completion of Post Offer Exam, or Completion of Work Simulation if applicable.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Additional Preferences:
5+ years' experience relevant to their area (makeup, inoc, MCC, purification, etc.)
Experience with computer systems such as SAP, Regulus/Syncade, Trackwise, Discoverant and LIMS Systems.
Experience operating process control systems (DeltaV, Unicorn) and using process historians (PI, Unicorn)
General interpersonal and communication skills; coaching, feedback, training, and fostering an environment for learning and open/honest communication.
Basic analytical and problem-solving skills.
Additional Information:
Work environment includes administrative and production settings.
Safety glasses, safety shoes, and appropriate gowning, such as Tyvek suits, are required in production areas.
Location: Indianapolis, IN at LTC-North: B360
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