Sr. Director - mRNA Process Development at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Ph.D. in Chemical Engineering, Biotechnology, Biochemistry, or a related field with 8-10 years of experience in process development for mRNA-based therapeutics or biologics in the biopharmaceutical industry
Proven track record and hands-on experience in process development for plasmid DNA production, IVT, purification, and characterization of nucleic acid products
Deep knowledge of mRNA CQAs, impurity profiles and strategies for removal
Experience with efficient experiment designs for process optimization, scale up, tech transfer and manufacturing support
Proven track record of defining robust control strategy for clinical and commercial manufacturing, successful process validation and regulatory submission (IND, IMPD, BLA, MAA etc.)
Strong leadership and people management skills; experience overseeing both internal teams and external CDMO/CRO collaborations
Excellent communication, ability to effectively lead a cross-functional team, prioritize activities to meet program goals and schedule

Responsibilities

Provide technical and strategic leadership for the end-to-end development of robust, scalable, and regulatory-compliant mRNA manufacturing processes
Guide microbial fermentation and plasmid DNA production
Establish optimized and scalable IVT platforms
Drive purification and impurity removal strategies to ensure high product quality and reproducibility
Partner with Analytical Development to define CQAs and develop characterization assays
Provide scientific oversight, coordinate and manage technology transfer, and troubleshooting for external manufacturing partners
Collaborate with cross-functional teams (e.g. Research, Analytical, Drug Product, Clinical and Regulatory) to align process development with clinical and regulatory strategies
Lead or support regulatory submissions
Support due diligence efforts in business development activities
Mentor and develop a high-performing matrix technical team capable of delivering on program and organizational goals
Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement

Skills

mRNA

Process Development

Plasmid DNA Production

In Vitro Transcription

IVT

Purification

Product Characterization

Microbial Fermentation

Scale Up

Impurity Removal

Critical Quality Attributes

CQA

Control Strategy

CDMO

CRO

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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