Director of Analytical Development & Characterization
Initial Therapeutics, Inc.
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Benefits offered by this job
Job summary
Lilly seeks a Senior Director/Director of Analytical Development & Characterization to define and lead the analytical science strategy for injectable biologics and complex delivery systems. You will oversee method development, validation, dissolution, and biophysical characterization, guiding IND-enabling decisions and cross-functional teams.
You will mentor scientists, collaborate with academia and CDMOs, and represent Lilly in regulatory discussions while advancing innovative analytics and
Qualifications
- Earned PhD in analytical chemistry, pharmaceutical sciences, chemistry, chemical engineering, or a related field.
- 8+ years of industry experience in pharmaceutical analytical development, including separation science and method development/validation.
- Bridge analytical method and characterization into IND/CMC-ready control strategies; knowledge of ICH Q2, design controls, and quality systems.
- Hands-on use of AI/ML-enabled tools to accelerate research and translational planning.
- Proven ability to lead, mentor, and develop technical talent; strong technical publication/patent record.
Responsibilities
- Define multi-year analytical development and characterization strategy for delivery-science platforms.
- Serve as internal/external technical authority on analytical development and translational work.
- Build external collaborations with academia, CDMOs, and regulators; represent Lilly externally.
- Oversee strategy for method, release, stability studies; drive data-driven decisions under ambiguity.
- Mentor scientists and engineers across teams; lead cross-functional improvements.
Skills
Education
Tools
Job description
Lilly seeks a Senior Director/Director of Analytical Development & Characterization to define and lead the analytical science strategy for injectable biologics and complex delivery systems. You will oversee method development, validation, dissolution, and biophysical characterization, guiding IND-enabling decisions and cross-functional teams.
You will mentor scientists, collaborate with academia and CDMOs, and represent Lilly in regulatory discussions while advancing innovative analytics and
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