Corporate Reference Standard & Development Stability Scientist

Lilly • Indianapolis, IN

58d • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for motivated individuals who are determined to make life better for people around the world. The Bioproduct Research and Development (BR&D) organization delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly’s deep pharmaceutical development expertise and engineering capabilities. In this role, we are seeking an experienced scientific leader that will have responsibility for ensuring the technical integrity, compliance, and business administration of a Lilly team responsible for development stability, reference standards, and critical related materials. The scientist will have influence in all phases of drug development, product registration and marketed product support by ensuring that development stability studies are properly managed and suitable reference standards are available and accurately assigned. The individual will ensure that materials and the certifying documentation are scientifically sound, properly integrated with analytical control strategies, and compliant with all corporate and regulatory requirements. The scientist will be an external leader in this technical area, set overall strategy at Lilly, and lead global Lilly scientists to ensure all related deliverables are met.

Requirements

• 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 over 15 years of experience in the pharmaceutical industry.

Nice To Haves

• 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.

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 advanced knowledge of 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 appropriate calculations, and defines how conclusions are made to support key 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.
• 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.
• 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

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees