Job Details

Operator Bioprocess Research Lab Fixed Duration Employment

Company name
Eli Lilly and Company

Location
Indianapolis, IN
18 hit(s)  

Profile

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

Location: LTC-North: B360

Specific Functions or Duties

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.

Basic Qualifications

High School Diploma/GED

Min 2 years experience relevant to their area (makeup, inoc, MCC, purification, etc.) or 2 year degree in biotechnology

Experience executing manufacturing tickets, following procedures and completing engineering protocols including the use of Word and Excel.

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

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

This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.

Work environment includes administrative and production settings.

Safety glasses, safety shoes, and appropriate gowning, such as Tyvek suits, are required in production areas.

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.

Company Profile
Lilly makes medicines that help people live longer, healthier, more active lives. We were founded by Eli Lilly in 1876, and are now the 10th largest pharmaceutical company in the world. We have steadfastly remained independent, but not isolated. Across the globe, Lilly has developed productive alliances and partnerships that advance our capacity to develop innovative medicines at lower costs. Lilly is consistently ranked as one of the best companies in the world to work for, and generations of Lilly employees have sustained a culture that values excellence, integrity and respect for people.

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