Director Corporate Reference Standard & Development Stability

Role Summary

Director Corporate Reference Standard & Development Stability. Lead a Lilly team responsible for development stability, reference standards, and related materials, ensuring technical integrity, compliance, and alignment with regulatory requirements throughout drug development, product registration, and marketed product support. Set overall strategy and lead global scientists to ensure deliverables are met.

Responsibilities

• Applies deep expertise in reference standards and stability science to solve complex technical challenges.
• Develops and maintains a robust quality system and business processes for reference standards and stability programs.
• Leverages analytical control strategies to guide material sourcing, packaging design, inventory management, equipment/facility oversight, protocol development, specification setting, and data evaluation.
• Leads global technical teams to integrate and interpret complex data sets from diverse sources, enabling data-driven decision-making.
• Establishes statistical techniques, defines calculations, and determines how conclusions support analytical testing and suitability decisions.
• Designs processes to ensure compliance with global regulatory requirements for reference standards and stability studies.
• Provides technical leadership, driving resolution of complex analytical issues.

Project Management

• Oversees planning and execution of material supply, storage, and distribution strategies aligned with material properties and intended use.
• Interprets performance metrics and trends to drive timely, data-informed actions.
• Builds and manages a network of internal and external partners to meet technical and capacity needs.
• Owns team workload management and ensures alignment with project demand.
• Ensures all activities comply with applicable regulatory and safety standards.

Customer Focus/External Focus

• Influences the external scientific community to adopt Lilly best practices and align Lilly with industry best practices
• Represents Lilly during external audits and in external interactions with key stakeholders

Qualifications

• A Ph.D. in analytical chemistry, bioanalytical chemistry, or a related discipline with at least 10 years of experience in the biopharmaceutical sector following graduation, or alternatively, a B.S./M.S. with 15+ years of experience in the pharmaceutical industry.

Skills

• Demonstrated leadership and ability to influence across internal and external teams.
• Deep expertise in analytical sciences, including measurement techniques, specifications, and statistical data analysis.
• Strong background in reference standards and stability science across diverse molecular modalities.
• Solid understanding of chemical synthesis, purification, formulation, packaging, and inventory management.
• Proficient in statistical tools and computerized systems such as LIMS and inventory management platforms.
• Strong communication and interpersonal skills, with a consistent record of collaboration.
• High attention to detail and ability to adapt to shifting priorities while managing ambiguity.
• Strong compliance mindset with thorough knowledge of regulatory and safety requirements.

Education

• Ph.D. in analytical chemistry, bioanalytical chemistry, or related field with relevant experience; or B.S./M.S. with extensive pharmaceutical industry experience.

Additional Requirements

• Travel: 5 to 10%
• Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)