Biologics Process Engineering Lead

BioSpace; Lebanon (IN); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Pension

Paid vacation

Medical benefits

Dental benefits

Vision benefits

Flexible benefits

Well-being programs

Job summary

Lilly is seeking an Associate Director, Biologics Process Engineering in Indianapolis to lead the biologics process engineering group and ensure resourcing, qualification, and compliant equipment for biologics drug substance manufacturing.

You will guide cross‑functional teams across upstream/downstream operations, set technical standards, and align with GMP, data integrity, and regulatory expectations as the Lilly Medicine Foundry site in Lebanon, Indiana scales up.

Qualifications

• Bachelor's degree in Engineering, Biochemical Engineering, Chemical Engineering, or related science.
• 5+ years of experience in a process engineering role in biologics manufacturing.
• Experience with upstream and/or downstream biologics unit operations.

Responsibilities

• Lead the biologics process engineering group and develop talent through coaching and development plans.
• Coordinate process engineering work across upstream and downstream unit operations.
• Set standards for engineering work products and align with GMP Quality Plan objectives.
• Ensure GMP compliance for facilities, processes, and documentation with data integrity focus.
• Oversee technical reviews, change controls, investigations, and regulatory-related documents.
• Partner in site planning for capital and resource allocation to support biologics portfolio.

Skills

Process engineering leadership

Biologics manufacturing knowledge

Upstream/downstream operations

Regulatory knowledge (FDA, ICH, cGMP)

Education

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

Tools

Bioreactors

Chromatography systems

Single-use technology

Process control systems (SCADA)

Job description

Lilly is seeking an Associate Director, Biologics Process Engineering in Indianapolis to lead the biologics process engineering group and ensure resourcing, qualification, and compliant equipment for biologics drug substance manufacturing.

You will guide cross‑functional teams across upstream/downstream operations, set technical standards, and align with GMP, data integrity, and regulatory expectations as the Lilly Medicine Foundry site in Lebanon, Indiana scales up.