Operator- Bioprocess Manufacturing

November 15 2017
Life Sciences
Position Type
Full Time
Organization Type
Job Type
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
The primary responsibilities of the position require:

•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.

Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Basic Qualifications
  • High School Diploma/GED
  • Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable
  • Min 2+ years experience relevant to their area (makeup, inoc, MCC, purification, etc.) or 2 year degree in biotechnology
  • 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 Skills/Preferences
  • Experience executing manufacturing tickets, following procedures and completing engineering protocols including the use of Word and Excel
  • Strong cGMP background; specific experience required in a regulated environment where both quality and safety regulations are being addressed on a daily basis
  • 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.
  • 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.
  • Position is located at LTC-North: B360
  • Shifts can vary for each area. Flexibility is required to accommodate different production shifts, possibly including night work.
  • Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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