Director, Analytical Chemistry - Antibody-Drug Conjugates at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization of antibody-drug conjugates
Familiarity with applicable regulatory requirements and emerging trends in the industry
Depth of knowledge in concepts relevant to linker payload, monoclonal antibody, drug substance, and drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, authoring regulatory submissions, and addressing questions from global regulatory agencies
High learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas to bring value across the antibody-drug conjugate portfolio

Responsibilities

Drive the implementation of technical solutions and analytical strategies to enable drug substance and drug product process design
Collaborate within project teams to deliver robust control strategies for drug substances and drug products and/or intermediates
Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ)
Provide technical guidance for analytical activities executed within the external network, ensuring methods are technically sound, well developed, and fit-for-purpose
Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites
Mentor and develop scientific staff, ensuring continued technical and professional growth, encouraging efforts towards excellence and knowledge sharing
Introduce new methodologies for optimization of antibody-drug conjugates

Skills

Analytical Chemistry

Antibody-Drug Conjugates

HPLC

Mass Spectrometry

NMR

Pharmaceutical Development

Regulatory Submissions

Monoclonal Antibodies

Therapeutic Proteins

Gene Therapy

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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