TSMS Senior/Principal Scientist APIEM TIDES at Eli Lilly and Company

Kinsale, County Cork, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Strong understanding of manufacturing principles and Lilly systems to ensure standards are applied to external contract manufacturers
Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards
Investigative mindset, skilled at critical thinking, and preference for collaborative working
Excellent communication skills to manage internal and external relationships, perform effective investigations, and disseminate actionable outputs
Experience with advanced data analytics to ensure Proven Acceptable Ranges (PAR) and Normal Operating Ranges

Responsibilities

Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes
Lead resolution of technical issues, including those related to control strategy and manufacturing
Build and maintain relationships with development partners and central technical organizations
Ensure proper characterization of processes and effective documentation and justification of the process description, measures, acceptable ranges, and specifications
Provide technical support for technical transfer, process stewardship, and process monitoring at external contract manufacturing groups to achieve reliable and compliant manufacture of API drug substance to global quality standards
Demonstrate a proactive attitude to issue resolution and interact daily with external partners, process team members, and site management
Work cross-functionally within the site and other functions to deliver on technical objectives

Skills

API Manufacturing

Technical Services

Manufacturing Sciences

Pharmaceutical Development

Process Chemistry

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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