Bioprocess Scientist - Advanced Therapies Manufacturing at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Advanced TherapiesIndustries

Requirements

In-depth knowledge of the science behind the molecule and the processes for gene therapy products
Understanding of the process control strategy for gene therapy products
Strong working skills on the manufacturing equipment set and control systems
Strong data-driven decision-making and problem-solving capabilities
Ability to build deep technical expertise in area of responsibility
Ability to assess whether the process is in control, capable of meeting its stated purpose, and in a constant state of validation

Responsibilities

Provide technical support for development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance for clinical and commercial manufacture
Provide technical support for all start-up TS/MS activities (e.g., NPI, tech transfer, process validation, process stewardship and improvement)
Ownership and technical stewardship of bioprocess and provide technical expertise during Root Cause Analysis for deviations and Impact Assessments for changes
Work as part of cross-functional teams, establish partnerships with applicable functions, operations, and development to understand interface between science/engineering and operations, and bring deep technical expertise to the team
Identify process improvements and participate in implementation of Lean manufacturing initiatives
Prepare, review, approve, and provide technical support for relevant technical documents (e.g., change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, process description documents, annual reports)
Support and/or lead TS/MS technical projects to ensure successful start-up, improve process control, yield, product quality, and/or productivity; implement process changes and improvements through the technical agenda
Develop, monitor, and appropriately react to established statistically based metrics
Ensure the process is in-control, capable, compliant, and maintained in a validated state through continual monitoring
Implement new technologies and process improvements in the manufacturing environment

Skills

Bioprocess

Gene Therapy

Manufacturing

Technical Services

Process Validation

Technology Transfer

Process Stewardship

Quality System

Clinical Manufacturing

Commercial 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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