Director - Engineering - Synthetic Molecule Design and Development (SMDD)

Role Summary

Director - Engineering - Synthetic Molecule Design and Development (SMDD) lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. Lead dynamic teams of process chemists, analytical chemists, formulation scientists, and engineers.

Responsibilities

• Possess fluent knowledge in unit operation design, process modeling, process equipment selection, and scale-up methodologies; create and apply cutting edge technology and novel platforms within a time constrained environment.
• Lead and/or supervise the design and development of new synthetic routes for the manufacture of active pharmaceutical ingredients using modern technologies including continuous processing, automated reaction screening, PAT, and modeling and simulation.
• Lead a cross-disciplinary team to evaluate and refine new manufacturing routes, technologies, and practices to deliver a challenging portfolio.
• Translate hypotheses into action and manage scientific uncertainty; encourage initiative and accountability within the team.
• Provide technical guidance in the scale-up and demonstration of new chemical processes in development and commercial scale equipment; participate in technology transfer activities to CRO/CMO organizations and Lilly manufacturing.
• Design laboratory experimentation to support process design, definition, optimization, and technology transfer; generate process and property design data using PAT and modeling platforms.
• Plan and manage short-term and long-term development activities; develop technical agendas and timelines; allocate resources and communicate progress.
• Collaborate with internal and external manufacturing partners to develop robust processes amenable to efficient drug substance manufacturing.
• Collaborate with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory scientists to deliver material and information for clinical trials and regulatory submissions.
• Embrace diverse thought and experience to deliver innovative solutions; demonstrate strong communication, organizational, and leadership skills.
• Supervise, mentor, and develop scientific staff; promote technical growth and knowledge sharing.
• Engage with external environment to apply external innovation across Lilly‚Äôs synthetic portfolio; understand the external regulatory climate and address CMC regulatory questions for clinical studies and marketing authorization.

Qualifications

• Minimum: Ph.D. in chemical engineering or closely related field with 8+ years of experience; or Master's degree with 15+ years of experience. Experience developing chemical processes from mid-development to product commercialization and transferring processes to manufacturing.
• Experience with development of active ingredients and related formulated products; familiarity with pharmaceutical sector preferred.

Skills

• Regulatory experience including authoring submissions and responding to regulatory questions.
• Modeling and simulation tools, data analytics, and predictive analytics.
• Process analytical technologies (PAT) and analytical techniques (online and offline).
• Technical project management, leadership, persuasion, negotiation, and collaboration.
• Strong communication, interpersonal, and organizational abilities; ability to influence and drive change.
• Experience with external publication and staying abreast of external scientific and regulatory landscape.

Education

• Ph.D. in chemical engineering or a closely related field or Master‚Äôs with substantial industrial experience as described above.

Additional Requirements

• Travel: 0 - 10%
• Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)