TSMS Lab Sr. Principal Analytical Scientist 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, HealthcareIndustries

Requirements

Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline with at least 10 years of relevant experience in the pharmaceutical or biotechnology industry; OR a Master’s degree with at least 12 years of relevant experience; OR a Bachelor’s degree with at least 15 years of relevant experience
Extensive hands-on experience and deep theoretical understanding of a broad range of analytical techniques, including chromatography (HPLC, GC, UPLC), mass spectrometry (LC-MS/MS, GC-MS), spectroscopy (UV-Vis, FTIR, Raman), and other relevant physiochemical characterization methods
Demonstrated ability to independently troubleshoot complex analytical challenges, conduct OOS investigations, and implement effective solutions
In-depth knowledge of cGMP, ICH guidelines, and other global regulatory requirements pertaining to analytical method development, validation, and quality control
Proven ability to provide technical leadership, mentor junior scientists, and influence technical direction within a team or project
Excellent written and verbal communication skills, with the ability to present complex scientific information clearly and concisely to diverse audiences
Strong interpersonal skills with a proven ability to collaborate effectively in a cross-functional team environment
Demonstrated track record of innovation

Responsibilities

Serve as a subject matter expert in analytical science, providing strategic direction and technical leadership for complex analytical projects within the TSMS Lab
Lead the design and development of complex LC-MS methods for the identification, quantification, and characterization of small molecules and peptides in support of API commercial manufacturing
Independently lead deviation investigations and process optimization initiatives using analytical methodologies, especially LC/MS
Proactively identify, evaluate, and implement new analytical technologies and instrumentation to enhance capabilities, improve efficiency, and support API manufacturing
Ensure all analytical activities are conducted in accordance with cGMP, ICH, and other relevant regulatory guidelines
Collaborate effectively with cross-functional teams including process development, manufacturing, quality control, and regulatory affairs; mentor and provide technical guidance to junior scientists and laboratory personnel
Critically analyze and interpret complex analytical data, generating comprehensive reports and presentations to communicate findings and recommendations to stakeholders
Maintain meticulous laboratory notebooks, author analytical method documentation, and technical transfer documents

Skills

Key technologies and capabilities for this role

LC-MSanalytical method developmentsmall molecule characterizationpeptide quantificationdeviation investigationsprocess optimizationcGMPICH guidelinesLC/MSAPI manufacturing

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with at least 10 years of relevant experience is required; alternatively, a Master's degree with 12 years or a Bachelor's with 15 years of experience in the pharmaceutical or biotechnology industry.

What key technical skills are needed for this position?

Extensive hands-on experience with analytical techniques including chromatography (HPLC), LC-MS methods for small molecules and peptides, and leading deviation investigations and process optimization using analytical methodologies.

Is this a remote position, or is it office-based?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this Senior Principal Analytical Scientist position?

Candidates with a Ph.D. and 10+ years of pharmaceutical industry experience, deep expertise in LC-MS and chromatography, proven leadership in complex analytical projects, and the ability to collaborate cross-functionally and mentor junior scientists stand out.

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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