Advisor/Senior Advisor – Process Chemistry Peptides & Oligonucleotides at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Experience in chemistry, manufacturing and control (CMC) of peptides and oligonucleotides
Fluent knowledge in modern synthetic organic, peptide, and nucleic acid chemistry methods
High learning agility to understand and exploit new scientific concepts and methods across multiple disciplines
Solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies

Responsibilities

Synthesize complex peptide/oligonucleotide active pharmaceutical ingredients (APIs) using both established and ground-breaking technologies in synthetic chemistry, chemical engineering, and continuous manufacturing
Challenge existing methods, define new manufacturing technologies, and apply those to deliver a portfolio and address key CMC challenges
Apply learnings to a portfolio of small molecule, oligonucleotide, synthetic peptide, and other emerging synthetic modalities
Provide technical leadership in the scale-up and demonstration of new chemical processes in development scale equipment
Collaborate with internal and external manufacturing partners to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing
Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver material and information for clinical trials and regulatory submissions
Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives
Support generating data to be used in regulatory filings and address key CMC regulatory questions that enable clinical studies
Identify, partner, and develop external chemistry innovations to complement existing internal capabilities and incorporate these innovations across the portfolio of assets
Lead CMC activities to support clinical trials and regulatory submissions of peptide/oligonucleotide therapeutics
Develop and work with both internal manufacturing (Lilly Medicine Foundry) and external contract manufacturing organizations (CMOs) to support synthesis, tech transfer, and campaign execution

Skills

Process Chemistry

Peptides

Oligonucleotides

CMC

Synthetic Peptides

Oligonucleotide Synthesis

Purification

Isolation

Formulation

Clinical Trials

Regulatory Submissions

Contract Manufacturing

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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