Biologics Process Engineering Director

Lilly Group; Indianapolis (IN); On-site; USD 123,000 - 180,000; Full time

Job summary

Lilly is seeking an Associate Director of Biologics Process Engineering to lead the biologics process engineering organization and ensure reliable, compliant manufacturing of biologics drug substances, including monoclonal antibodies and bioconjugates. The role spans startup to ongoing operations and requires cross-functional collaboration across upstream and downstream units in a GMP environment.

The position emphasizes technical leadership, regulatory alignment, and continuous improvement to

Qualifications

• Bachelor's degree in Engineering, Biochemical Engineering, Chemical Engineering, or related science field.
• 5+ years of experience in a process engineering role supporting biologics drug substance manufacturing or development activities, preferably in a GMP manufacturing environment.
• Demonstrated experience with upstream and/or downstream biologics unit operations (bioreactors, chromatography, filtration, formulation).

Responsibilities

• Lead the biologics process engineering group through recruitment, supervision, coaching, and development planning.
• Provide process engineering work coordination and guidance to key functional groups supporting biologics manufacturing operations (upstream and downstream units).
• Set and reinforce standards for engineering work product and first-principles approach; influence technical agenda and GMP objectives.
• Ensure GMP compliance of facilities, processes, and documentation, maintaining site inspection readiness.

Skills

Leadership

Process engineering

Biologics manufacturing

GMP compliance

Cross-functional collaboration

Regulatory knowledge

Project startup

Change controls

Education

Bachelor's degree in Engineering, Biochemical/Chemical or related science

Tools

SCADA systems

Bioprocess equipment

Single-use technology systems

Job description

Lilly is seeking an Associate Director of Biologics Process Engineering to lead the biologics process engineering organization and ensure reliable, compliant manufacturing of biologics drug substances, including monoclonal antibodies and bioconjugates. The role spans startup to ongoing operations and requires cross-functional collaboration across upstream and downstream units in a GMP environment.

The position emphasizes technical leadership, regulatory alignment, and continuous improvement to