Bioprocess Scientist - External Projects - Advanced Therapies Manufacturing

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 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.

Lilly is currently constructing a cutting edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. 

This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Position Description:

The Bioprocess – Technical Services/Manufacturing Science (TS/MS) role provides technical support to ensure the reliable and compliant manufacture of gene therapy drug substance at external contract manufacturing groups and, when needed, at LP2, in accordance with global quality standards. This person interacts daily with a wide variety of people, including external partners, process team members and site management.

The candidate will be responsible for technical transfer, process validation, process stewardship and process monitoring, and will demonstrate a proactive attitude to issue resolution. A strong understanding of manufacturing principles is required to ensure those same standards are applied to the external contract manufacturers. The incumbent would preferably possess an investigative mindset and be skilled at critical thinking with a preference for collaborative working.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards. The position requires working cross-functionally within the site and other functions to deliver on technical objectives.

Key Objectives/Deliverables

• Have an in-depth knowledge of the science behind the molecule and the processes. Understand the process control strategy for gene therapy products.
• Provide technical oversight and stewardship for manufacturing activities (e.g., tech transfer, process validation, frontline support and improvement).
• Understand the scientific principles required for manufacturing drug substances, including stir-tank bioreactor, chromatography operation, TFF, viral filtration and aseptic processes.
• Leads resolution of technical issues including those related to control strategy and manufacturing.
• Employ excellent communication skills to manage internal and external relationships, perform effective investigations and disseminate actionable outputs.
• Build and maintain relationships with development partners and central technical organizations.
• Ensure proper characterization of processes and ensure effective documentation and justification of the process description, measures, acceptable ranges, and specifications. Experience with advanced data analytics to ensure that Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) align with process capability.
• Ensure that processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring. Identify any leading signals of process weakness from yield/quality standpoint and proactively resolve/escalate.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation.
• Support regulatory submissions with technical input as required, author and review annual reports to regulatory agencies and maintain awareness of regulatory best practices.
• Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls in place.
• Prepare, review, approve