Scientist – API Manufacturing Process Support at Eli Lilly and Company

Indianapolis, Indiana, United States

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$64,500 – $167,200Compensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Strong understanding of scientific principles related to pharmaceutical manufacturing
Ability to execute technical projects, including experimental design, data analysis, and modeling
Experience with process control, yield optimization, and purity enhancement
Technical proficiency in setting up and executing experiments at the laboratory scale
Ability to analyze data and ensure accurate documentation
Knowledge of Good Manufacturing Practices (GMP) and Chemical Hygiene Practices (CHP)
Ability to independently set up and execute various chemical reactions
Ability to write technical reports and documentation

Responsibilities

Understand the scientific principles required for manufacturing intermediates and bulk drug substances
Execute technical projects (experimental, modeling, and/or production data analysis) to improve process control, yield, purity, and/or productivity
Provide technical support for the preparation of relevant technical documents, including:
Technical reports
Change controls
Regulatory submissions
Deviation investigations
Validation protocols
Summary reports
Processing records
Procedures
PFDs (Process Flow Documents)
VMPs (Validation Master Plans)
Develop and monitor established metrics in real-time to assess process variability and capability
Understand, justify, and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose
Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps
Provide support to internal and joint process teams and to the global and local PLOT (Process Liaison, Operations Team) teams
Utilize safe laboratory practices and adhere to CHP requirements
Conduct research on manufactured product for process improvements and troubleshooting

Skills

GMP

process control

yield optimization

purity enhancement

experimental design

data analysis

modeling

chemical reactions

technical reports

change controls

regulatory submissions

deviation investigations

validation protocols

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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