Associate/Sr. Associate Manufacturing Scientist - Small Molecule - 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 in STEM Discipline (Chemistry preferred)
2+ years of experience in cGMP manufacturing (pharmaceutical manufacturing experience preferred)
Demonstrated understanding of process chemistry (preferred)
Demonstrated basic knowledge in small molecule, peptide, or oligonucleotide API Manufacturing (preferred)
Relevant industrial experience in any of the following disciplines such as 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 initiative and as part of a Process Team consisting of a diverse group of management, production, science (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, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs (Process Flow Documents), VMPs, 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 (tickets & 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
Ability to analyze data and ensure appropriate documentation
Write technical reports and documents

Skills

Key technologies and capabilities for this role

GMPAPI ManufacturingSmall MoleculeProcess OptimizationData AnalysisProcess ModelingLaboratory ExperimentsTroubleshootingProcess ControlYield ImprovementPurity Analysis

Questions & Answers

Common questions about this position

What is the location of this position?

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

Is this a remote position?

This information is not specified in the job description.

What salary or compensation does this role offer?

This information is not specified in the job description.

What key skills are required for the Manufacturing Scientist role?

Candidates need to understand scientific principles for manufacturing intermediates and bulk drug substances, including chemistry-equipment interactions, execute technical projects like experiments and data analysis to optimize processes, and provide support for technical documents such as reports, change controls, and validation protocols.

What makes a strong candidate for this position?

A strong candidate will have expertise in small molecule API manufacturing, experience with laboratory-scale experiments, process optimization, data analysis, and GMP technical support, and be ready to join a startup team for a greenfield 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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