Eli Lilly and Company · 3 days ago
Director Corporate Reference Standard & Development Stability
Indianapolis, IN
Full-time
Onsite
Director/Executive
$148K/yr - $257K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The role seeks an experienced scientific leader to ensure the technical integrity and compliance of a team responsible for development stability and reference standards, influencing all phases of drug development and product registration.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-06
2026-01-06
Company data provided by crunchbase