Senior Director, ADC Process Development at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Ph.D. and M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
A minimum of 8 years of industry experience (with a Ph.D.) or 15 years (with an M.S.) in small molecule process development
Demonstrated experience leading technical teams and managing people, ideally across multiple functions
Strong track record of successful IND/IMPD/BLA submissions and regulatory interactions
Deep understanding of CMC workflow, process development and scale-up, tech transfer, and GMP manufacturing
Excellent engagement, communication, leadership, and organizational skills
Additional Skills and Preferences
Experience with linker-payload design and conjugation technologies for ADCs
Experience with regulatory filings for ADC projects
Expertise in handling high-potency APIs in laboratory and GMP settings
Experience working in a matrixed biotech/pharma environment or with external partners

Responsibilities

Build and lead a multidisciplinary team of scientists and engineers, managing resources to meet project and program objectives
Develop and implement short- and long-term CMC strategies to support a growing portfolio pipeline, while balancing internal and external resource requirements and constraints
Collaborate with internal stakeholders (e.g., Discovery, Analytical, Drug Product, Quality, Regulatory, CMC PM) and external CDMOs to align and execute the CMC development plan
Create and update end-to-end capacity models, provide important data for business planning
Drive the design, scale-up, and tech transfer of small molecule payload and linker synthesis processes in support of ADC development
Oversee development and optimization of conjugation processes for early and late-stage clinical projects
Work with HSE to establish and enforce safety protocols for handling ADC payloads, linkers, and conjugates in development labs
Contribute to regulatory submissions (IND, IMPD, BLA/MAA), authoring high-quality CMC sections
Help drive innovation and evaluate emerging technologies to enhance platform capabilities

Skills

ADC Process Development

Small Molecule Process Chemistry

Conjugation Processes

CMC Strategy

Team Leadership

Cross-Functional Collaboration

CDMO Management

Biologics

Drug Product Development

Regulatory Affairs

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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