Director Process Chemistry SMDD

Responsibilities

• Demonstrate a deep expertise and demonstrated capability with utilization of modern synthetic organic and process chemistry techniques to address key CMC challenges
• Lead and/or supervise the design and development of new synthetic routes for the manufacture of API using the most modern technologies
• 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 portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging synthetic modalities
• Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies; build and apply groundbreaking technology and novel platforms within a time constrained environment
• Lead a cross-disciplinary team to evaluate and refine new manufacturing routes, manufacturing technologies, and practices to deliver an exciting portfolio
• Provide technical leadership in the scale-up and demonstration of new chemical processes in development and commercial scale equipment; 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
• 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
• 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
• Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing authorization applications
• 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 demonstrates an ability to recognize and integrate external innovation across the Lilly synthetic portfolio

Qualifications

• Ph.D. in organic chemistry, or a related field with 10+ years of pharmaceutical process development experience OR MS in Organic Chemistry or related field with 15+ years' experience