Director Engineering - Synthetic Molecule Design and Development

Position Summary

Our team is looking for experienced, creative, and energetic candidates to lead unit operation development and process optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity to lead dynamic teams comprised 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 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 these 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.
• Lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver a challenging portfolio.
• Comfortable with scientific uncertainty and the ability to translate hypotheses into action.
• Encourage team members to take initiative and accountability to achieve goals; draw out and encourage others to share knowledge.
• 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 to ensure processes are technically sound, well developed and characterized, and safe.
• Design laboratory experimentation in support of process design, definition, optimization, and technology transfer objectives.
• Generate process (and property design) data based on a fundamental understanding of the underlying physical processes.
• Utilize advancements in technology (PAT) and modeling platforms to understand and direct experimental protocols.
• Plan and manage short term and long-term development activities.
• Develop and/or review technical agendas and timelines for project work.
• Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Collaborate with internal and external manufacturing partners to develop robust chemical processes readily amenable to efficient drug substance manufacturing.
• Collaborate closely with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory scientists to execute and deliver material and information for clinical trials and regulatory submissions.
• Embrace diverse thought, background, and experience to deliver innovative solutions.
• Possess strong communication (oral, written), organizational, and leadership skills.
• Supervise, mentor and develop scientific staff; ensure continued technical and professional growth of group members.
• Active participant in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.
• Possess deep understanding of the external global regulatory climate and emerging requirements.
• Address key CMC regulatory questions that enable clinical studies and support marketing authorization applications.

Basic Qualifications

• Ph.D. in chemical engineering or a closely related field with 8+ years of experience; or MS degree with 15+ years of experience.
• Experience developing chemical processes from mid-development cycle (proof of concept) to product commercialization required.
• Experience with technical transfer of processes into manufacturing operations required.

Additional Skills/Preferences

• Experience with authoring regulatory submissions and responding to regulatory questions.
• Experience with modeling and simulation tools, data analytics, and predictive analytics.
• Experience with online and offline analytical techniques and process analytical technologies (PAT).
• Strong technical skills to supply business value.
• Creativity and ability to transform ideas into marketable products and processes.
• Knowledge and experience with management of a technical project.
• Demonstrated leadership capabilities especially in a team environment.
• Demonstrated ability to drive and accept change.
• Demonstrated success in persuasion, influence and negotiation.
• Good interpersonal skills and a sustained tendency for collaboration.
• Ability to prioritize multiple activities and manage ambiguity.
• Ability to influence others to promote a positive work environment.
• Understanding and awareness of the external scientific and regulatory landscape.
• Demonstrated initiative and risk-taking.
• Demonstrated technical proficiency and ability to create ideas for future work plans.
• Established external publication record.