Engineering Technical Director, Drug Substance Manufacturing

Eli Lilly and Company • Indianapolis, IN

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About The Position

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. Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Organization Overview: The Bioprocess Operations team within Bioproduct Research and Development (BRD) is responsible for the GMP manufacture of drug substance (DS) to support clinical trials within the BRD portfolio. This includes the internal manufacture of monoclonal antibodies, bioconjugates and adeno associated viruses, as well as oversight of DS manufacturing at qualified collaboration partners. The technical director of engineering will consult with process development and manufacturing network partners to ensure facility fit for process technical transfers, advise on new manufacturing facility designs, and implement new technology. In addition, the technical director 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 process equipment within the Bioprocess Pilot Plant. The main focus area of this role is in purification and conjugation technologies in support of GMP manufacturing.

Requirements

• Ph.D. in Chemical Engineering or a related field with 8-10 years of experience in process development or biologics manufacturing or a BS/MS in Chemical Engineering or a related field with 15+ years of experience in process development or biologics manufacturing.
• Strong experience in biopharmaceutical production unit operations for downstream processing
• Design and qualification of downstream equipment
• Strong oral and written communication skills with a demonstrated ability to communicate across a wide variety of audiences, e.g., technical personnel, operations, and management.
• Strong problem-solving skills.
• Ability to provide technical leadership across diverse teams.
• Experience with process control systems like Unicorn or DeltaV

Responsibilities

• Provide technical expertise and oversight to assist in the design and operation of manufacturing processes, with a focus on chromatography, filtration and bulk unit operations.
• Develop control systems for unit operations and process improvements.
• Perform impact and risk assessments for new processes, unit operations and technology.
• 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, as required, that enhance current capabilities and align with commercial manufacturing needs.
• Provide engineering support for tech transfers to internal and external manufacturing (commercial and clinical) sites, as required.
• Teach, mentor and ensure knowledge transfer to other engineers and scientists within the organization.
• Ensures processing equipment and technology remain compliant with PR&D Quality System requirements, applicable engineering standards, and cGMP requirements.
• Provide technical input and impact assessment for global and local Quality Standards and SOPs, as requested.
• Participate in audits (internal and external), as requested.
• Support regulatory submissions and response to questions, as requested.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree