Director Late Phase Process Development SMDD

Position Summary

Our team is looking for experienced and creative individuals to lead late-phase synthetic molecule process development. This includes finalizing the commercial route and process, characterizing the process, and defining the control strategy to support Phase 3 clinical supply, registration stability, regulatory submissions, process validation, and commercial hand-off. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, material scientists, and engineers. Additionally, candidates will provide oversight for external R&D, tech transfer, and campaign execution.

Responsibilities

• Demonstrate a deep expertise and demonstrated capability in the utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges
• Lead and/or supervise the finalization of commercial synthetic routes and the development of robust, scalable, and well-characterized API manufacturing processes, including starting materials selection and justification of the commercial route
• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives
• Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple fields; be able to apply these takeaways to a dynamic portfolio of small molecule programs
• Possess solid understanding in unit operation design and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment
• Apply risk-based process characterization, design space definition, and control strategy development to ensure readiness for process validation and commercial manufacture
• Leverage predictive modeling, simulation, and machine learning to inform design space definition, impurity fate and purge, scale-up, and control strategy, reducing experimental burden and strengthening regulatory justification
• Lead a cross-disciplinary team to refine manufacturing routes and manufacturing technologies to advance an exciting small molecule portfolio
• Deliver commercial-ready manufacturing processes, including impurity control, process robustness, and lifecycle strategy, and enable effective handoff to internal and external commercial manufacturing sites
• Collaborate in technology transfer activities to CRO/CMO organizations and internal Lilly manufacturing nodes to ensure processes are technically robust, well developed and characterized, and safe
• Integrate process and property data with a fundamental understanding of the underlying physical processes; build and apply mechanistic, kinetic, and data-driven models to predict process performance and guide development decisions
• Utilize modern artificial intelligence and machine learning tools to accelerate development and deepen process understanding
• Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver material and information for clinical trials and regulatory submissions
• Embrace diversity in thoughts, background, and experiences through supervision, mentoring, and development of a diverse scientific staff to deliver solutions
• Encourage team members to take initiative and accountability to achieve goals and draw out and encourage others to share knowledge on challenging technical issues
• Actively collaborate and exhibit influence in the external scientific environment and demonstrate an ability to recognize and integrate external innovation across the Lilly synthetic portfolio

Minimum Qualifications

Ph.D. in organic chemistry, or a related field with 8+ years of pharmaceutical process development experience OR MS in Organic Chemistry or related field with 15+ years' experience.

Additional Skills/Preferences

• Experience within the pharmaceutical sector is preferred; however, other experience may meet expectations
• Prior experience in active ingredient development and associated formulated product is acceptable
• Experience with developing chemical processes for Phase 3 through commercialization of small molecule projects
• Experience with technical transfer of processes into manufacturing operations
• Experience with authoring regulatory submissions and responding to regulatory questions
• Established external reputation and strong publication record
• Knowledge and experience with management of a technical project and ability to build ideas for future work plans
• Experience with modern analytical techniques and process analytical technologies (PAT)
• Experience applying Quality by Design (QbD) principles, design of experiments (DoE), and risk assessments to establish process understanding, proven acceptable ranges, and design space
• Plan and lead short term and long-term development activities; develop and/or review technical agendas and timelines for project work; advise resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction
• Experience with modeling and simulation tools, data analytics, predictive analytics, and AI/ML
• Ability to transform ideas into marketable products and processes
• Demonstrated leadership capabilities, good communication skills and a sustained tendency for collaboration
• Ability to prioritize multiple activities and handle ambiguity
• Ability to influence others to promote a positive work environment