Technical Lead Scientist - Advanced Therapies Manufacturing at Eli Lilly and Company

Lebanon, 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, BiotechnologyIndustries

Requirements

Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug products for gene therapy products commercialization
Provide product and process technical knowledge to identify appropriate manufacturing approaches for processing of new products
Support identification and development of new manufacturing technologies and processes to support commercialization
Lead risk management activities as it pertains to new products (FMEA)
Own Tech Transfer strategy for the manufacturing site
Ensure that an accurate instruction set (eBRs and procedures) and PFD describe the process and control strategy for new products
Drive technical excellence through meaningful specifications, including approval of local specifications and influencing global specifications
Understand, justify, and document the process validation strategy for new products

Responsibilities

Provide technical leadership and oversight to clinical and commercialization activities of gene therapy product at the Lebanon Advanced Therapies (LP2) site
Scope includes all clinical trial and commercialization gene therapy products such as technology transfer, validation, drug substances and products production, inspection, submission and filing
Involved with clinical trials and supports all commercialization activities up to submission and approval of the DP by providing technical support to ensure processes are in alignment with Lilly Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and LP2 commercialization procedures
Work with functional teams such as Engineering, Operations, Quality and Regulatory as well as other local/global teams throughout the commercialization process
Prepare, review, approve, and provide technical support for preparation of relevant documentation

Skills

Gene Therapy

Process Validation

Technology Transfer

Advanced Manufacturing

Data Analysis

Process Stewardship

Bioprocessing

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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