Director - Engineering - Purification & Conjugation Technologies - BR&D

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 Biologics 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.

Responsibilities

• Provide technical expertise and oversight to assist in the design and operation of manufacturing processes for drug substance, with a focus on chromatography, filtration and bulk unit operations (large scale).
• 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.

Basic Requirements

• Ph.D. in Chemical Engineering or a related field with 8+ years of experience in process development or biologics manufacturing or a BS/MS in Chemical Engineering or a related field with 10-12+ 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

Additional Information

• Position is 8 hour days with flexibility to support activities during shutdowns, weekends, etc.
• Travel is possible, but expected to be minimal

Physical Demands/Travel

The physical demands of this job are consistent with a manufacturing environment.

Work Environment

This position’s work environment is in a manufacturing environment.

Equal Employment Opportunity

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

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