Scientific Director/Sr. Director/Executive Director - Process Chemistry - Oligonucleotides

About This Role

Lead the development of synthetic drug substances and drug products from pre-clinical phase through commercialization, specializing in oligonucleotide process chemistry. This role supports the rapidly evolving Lilly Genetic Medicines portfolio and involves leading CMC activities.

Responsibilities

• Bring extensive knowledge of oligonucleotide development to SMDD and grow internal capabilities through coaching, mentorship, and leadership
• Possess fluent knowledge in modern synthetic organic and nucleic acid chemistry methods to challenge existing methods and define new manufacturing technologies
• Lead a cross-disciplinary team to evaluate and refine manufacturing routes, technologies, and practices for the LGM portfolio
• Exhibit high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines
• Provide examples of novel contributions to chemical design and mechanism-based problem solving, reflected in a strong publication record
• Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies
• Provide technical leadership in the scale-up and demonstration of new chemical processes in development and commercial scale equipment
• Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver materials and information for clinical trials and regulatory submissions
• Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives
• Possess deep understanding of the external global regulatory climate and emerging requirements to address key CMC regulatory questions

Requirements

• PhD degree in a relevant scientific discipline with 5+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC) OR MS degree with 8+ years of relevant experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC)
• Extensive knowledge of oligonucleotide development
• Fluent knowledge in modern synthetic organic and nucleic acid chemistry methods
• Solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies
• Deep understanding of the external global regulatory climate and emerging requirements

Qualifications

• PhD degree in a relevant scientific discipline
• 5+ years of experience (synthesis, oligonucleotide experience, solid phase synthesis, CMC) with a PhD; 8+ years with an MS

Nice to Have

• Experience within the pharmaceutical sector
• Experience in active ingredient development and associated formulated product
• Experience with developing chemical processes from mid-development cycle to product commercialization
• Experience in development / CMC including quality and regulatory interactions
• Experience with technical transfer of processes into manufacturing operations

Skills

* Required skills

Benefits