Director - Engineering - Synthetic Molecule Design and Development; SMDD

Overview

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

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

At Lilly, Synthetic Molecule Design and Development (SMDD) is involved in key activities for the development of synthetic active pharmaceutical ingredients from pre-clinical phases through commercialization of drug substances and drug products. Our scientists and engineers develop key technical and business solutions across the portfolio using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development.

SMDD delivers on these responsibilities by recognizing diverse talent and cultures are necessary to bring the next generation of life changing medicines to patients.

• Lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization.
• Lead dynamic teams comprised of process chemists, analytical chemists, formulation scientists, and engineers.
• Possess fluent knowledge in unit operation design, process modeling, process equipment selection, and scale-up methodologies with a drive to challenge existing methods; create and apply cutting edge technology and novel platforms within a time constrained environment.
• Familiarity and working knowledge of modern synthetic organic chemistry.
• Demonstrate high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; apply learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide modalities.
• 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.
• Ability to lead a cross-disciplinary team to evaluate and refine new manufacturing routes, technologies, and practices to deliver a challenging portfolio.
• Translate hypotheses into action in the face of scientific uncertainty.
• Encourage team members to take initiative and accountability; draw out and encourage knowledge sharing.
• Provide technical guidance in scale-up and demonstration of new chemical processes in development and commercial scale equipment; participate in technology transfer activities to CRO/CMO and Lilly manufacturing to ensure processes are technically sound, well developed and characterized, and safe.
• Design laboratory experimentation to support process design, definition, optimization, and technology transfer objectives; generate process and property design data based on fundamental physics; utilize PAT and modeling platforms to direct experimental protocols.
• Plan and manage short-term and long-term development activities; develop and/or review technical agendas and timelines; allocate resources and communicate progress or timeline changes.
• Collaborate with internal and external manufacturing partners to develop robust chemical 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, background, and experience to deliver innovative solutions.
• Possess strong communication, organizational, and leadership skills.
• Supervise, mentor and develop scientific staff and foster ongoing technical and professional growth; promote…