Advisor - Engineering, BRD Bioprocess Ops

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Organization Overview:

This position is part of the Bioproduct Research and Development (BRD) organization within Lilly Research Labs.  The BRD Clinical Trial (CT) manufacturing facility is focused on new protein therapeutics to market by producing bulk drug substance (API) for clinical trials, along with the associated technical data and documentation to support GMP activities.

Responsibilities:

The individual in this role will utilize a holistic understanding of process operations, engineering fundamentals, and cGMP requirements to provide leadership and technical oversight for the design, implementation, and lifecycle management for the processes within the Bioprocess Pilot Plant.  In addition, this individual will consult with manufacturing network partners to ensure facility fit for process technical transfers and advise on new manufacturing facility designs.  The individual in this role has the following responsibilities:

• Provide technical expertise and oversight to assist in the design and operation of manufacturing processes.

• Develop control systems for unit operations and process improvements.

• Perform impact and risk assessments for new processes and unit operations.

• Provide technical support in the pilot plant, e.g., troubleshooting process and equipment issues, leading process change controls, and consulting on process and equipment deviation investigations.

• Collaborate with development scientists and commercial manufacturing to ensure that technology adoption and integration is aligned to strategies of the broader organization.

• Maintains awareness of new and developing technologies to evaluate and implement that enhance current capabilities and/or improve facility capacity or operational efficiencies.

• Provide support for tech transfers to internal and external manufacturing (commercial and clinical) sites, as required.

• Provide technical oversight of external drug substance manufacturing processes for clinical trial supply, as required.

• Teach, mentor and ensure knowledge transfer to engineers and scientists within the organization.

• Support the qualification of new equipment/facilities.

• Provide technical input and impact assessment for PR&D Quality Standards and SOPs, as requested.

• Participate in audits (internal and external), as requested.

• Support regulatory submissions and response to questions, as requested

Basic Requirements:

• BS or MS in chemical engineering, biological engineering, related discipline and 10+ years of experience; or PhD with 0-6 years of experience

• Experience with large scale column chromatography

• Experience in biopharmaceutical production unit operations supporting antibody or protein purification operations

Additional Skills/Preferences:

• Proficiency in UNICORN Software

• Ability to work well in a team environment incorporating a variety of functional relationships and desire to be point of accountability.

• Strong oral and written communication skills for a diverse audience, e.g., both operations staff and management.

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