Associate Director Biologics Process Engineering Lilly Medicine Foundry
Overview
Lead a technically advanced biologics process engineering group at the new Lilly Medicine Foundry. Establish and grow a high-performing team focused on manufacturing for biologics. Drive process improvements and ensure GMP compliance. Partner with engineering and functional groups to align with site business goals. Differentiate this role by its focus on scaling a cutting-edge facility from concept to GMP readiness.
What You'll Do19
- 1Establish a technically advanced biologics process engineering group through recruitment and coaching
- 2Provide process engineering coordination and guidance to upstream and downstream functional groups
- 3Set and reinforce standards for engineering work product using first principles thinking
- 4Partner with engineering to influence technical agendas and site business plan objectives
- 5Ensure appropriate process engineering support for biologics operations including troubleshooting and scale-up
- 6Oversee engineering-related technical issues and technology upgrades specific to biologics unit operations
- 7Review and approve engineering deviations and change controls while maintaining GMP compliance
- 8Ensure all process engineering activities align with data integrity requirements
- 9Technical review and approval of key documents including validation reports and process characterization studies
- 10Identify and report functional performance indicators to drive continuous improvement
- 11Serve as System Owner for control systems including bioreactor SCADA and process chromatography
- 12Interact with regulators and stakeholders on business issues and audit support
- 13Network globally to share best practices among Lilly biologics manufacturing sites
- 14Build the biologics process engineering organization during the startup phase (2025-2027)
- 15Develop and implement systems and processes to achieve operational excellence at the new facility
- 16Support lean principles in process development and site operations
- 17Collaborate with cross-functional teams to deliver the facility to GMP readiness
- 18Lead process engineering efforts and make autonomous decisions within the team
- 19Foster teamwork and demonstrate interpersonal skills within a diverse group
Requirements10
- 1Bachelor's degree in Engineering Biochemical Engineering Chemical Engineering or related field
- 25+ years experience in process engineering supporting biologics drug substance manufacturing
- 3Thorough understanding of upstream and downstream biologics unit operations
- 4Experience with single-use technology systems and biologics regulatory submissions
- 5Familiarity with biologics-specific contamination control and cGMP/HSE regulations
- 6Proficiency in process characterization and validation requirements
- 7Experience with cell culture media feed strategies and viral clearance
- 8Ability to collaborate effectively and influence diverse groups
- 9Strong problem-solving skills and decision-making capabilities
- 10Commitment to patient-focused outcomes and improving lives through biologics
Salary Insight
$123 - $180k per year
Location
Required Skills
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