Associate Director - Engineering API External Manufacturing Peptides & Large Molecules

Role Summary

Associate Director - API EM Engineering Leader for Peptides and Large Molecule, providing leadership and expertise to reliably supply and commercialize externally manufactured APIs, intermediates and starting materials with safety first and quality always. Role involves increasing technical complexity and commercialization activity as the pipeline progresses.

Responsibilities

• Provide API EM organizational Engineering leadership for Peptides and Large Molecule as a member of the APIEM Plant Lead Team, HSE Lead Team, Science Lead Team, and co-lead the Engineering Lead Team
• Coach and mentor engineering associates in fundamental engineering support, including process knowledge, problem solving and engineering design
• Provide administrative oversight and support to a team of process engineers across multiple geographies
• Develop and provide ongoing leadership for a PSM program within API EM with the goal of improving PSM capabilities and performance at CMs
• Assess HSE and PSM capabilities of each CM impacting Lilly products during sourcing and lifecycle management
• Ensure FUME assessments of CMs to understand risks to Lilly’s control strategy are completed and maintained
• Lead internal resources and partner with CM resources in the execution of HSE, PSM and FUME capability assessments of CMs
• Lead internal resources and partner with CMs through specification, procurement, and IQ/OQ/PQ of equipment to ensure capital projects at CMs are delivered on time, within budget and meeting technical expectations
• Adhere to Lilly Red Book expectations when interacting with API EM’s CMs

Qualifications

• Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive pharmaceutical manufacturing experience
• 7+ years of experience in manufacturing operations and process engineering related roles

Additional Preferences

• Ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement
• Experience managing capital delivery projects or commercialization/technical agenda projects
• Deep technical knowledge of bulk API manufacturing equipment and unit operations
• Ability to influence integration points with other business areas, processes, and functions
• Experience with commercialization (Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE)
• Ability to function as a leader and team member in a collaborative environment
• Ability to manage and prioritize competing priorities with effective communication
• Experience in unit operations for large molecule expression and purification and small molecule manufacture
• Process Hazard Analysis experience
• Project management qualifications or ability to develop detailed project plans including critical path and risk register analysis

Skills

• Engineering leadership
• HSE and PSM program development
• Process engineering and problem solving
• Cross-functional collaboration
• Communication (verbal and written)

Education

• Bachelor of Science in Chemical Engineering or related field