Associate/Sr. Associate Manufacturing Scientist - Peptides - Lebanon API at Eli Lilly and Company

Lebanon, Indiana, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor's degree in STEM Discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or Master's degree and 1 year experience in cGMP manufacturing
Demonstrated knowledge in peptide synthesis (preferred)
Relevant industrial experience in API Manufacturing, TS/MS (Technical Services/Manufacturing Sciences), Quality Control, Quality Assurance, or Development (preferred)
Familiarity with cGMP manufacturing environment and terminology (preferred)
Excellent analytical, interpersonal, written and oral communication skills (preferred)
Ability to work on own initiatives and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals (preferred)

Responsibilities

Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment
Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity
Provide technical support for preparation of relevant technical documents, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), Validation Master Plans, Operational and Process Control Strategy etc
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 (batch production records & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps
Ensure that experiments are well designed with clear objectives
Investigate deviations using appropriate tools to ensure quality of the product

Skills

Key technologies and capabilities for this role

GMP ManufacturingAPI ProductionPeptide ManufacturingProcess OptimizationProcess ControlYield ImprovementPurity AnalysisData AnalysisLaboratory ExperimentsTroubleshootingTechnical ServicesManufacturing Science

Questions & Answers

Common questions about this position

What is the employment type for this position?

This is a full-time position.

Where is this job located?

The role is based at Lilly's advanced manufacturing facility in Lebanon, IN.

What skills are required for the Manufacturing Scientist role?

Key skills include understanding scientific principles for manufacturing intermediates and bulk drug substances, executing technical projects like experiments, modeling, and data analysis to improve process control, yield, purity, and productivity, and providing technical support for documents such as reports, change controls, and validation protocols.

What is the team structure for this role?

The Manufacturing Scientist is part of the TSMS (Technical Services/Manufacturing Science) team that provides technical support for reliable and compliant manufacturing, and will be part of the Manufacturing Process Team for its respective area.

What makes a strong candidate for this Manufacturing Scientist position?

A strong candidate will have expertise in peptide manufacturing, experience setting up and executing laboratory experiments, capability in process improvements and troubleshooting, and the ability to contribute to a startup team for a greenfield GMP manufacturing site.

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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