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

Indianapolis, Indiana, United States

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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
Knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards
Investigative mindset, critical thinking skills, and preference for collaborative working
Excellent communication skills for managing internal and external relationships
Experience with advanced data analytics to align Proven Acceptable Ranges (PAR) and Normal Operating Ranges (NOR) with process capability
Ability to work cross-functionally within the site and other functions

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, effective documentation, and justification of process description, measures, acceptable ranges, and specifications
Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state through process monitoring; identify and proactively resolve/escalate leading signals of process weakness
Understand, justify, and document the state of validation with data evaluating process capability
Initiate deviation records, ensure on-time closure with appropriate CAPAs and effectiveness checks; apply structured approach to problem solving and investigation
Support regulatory submissions with technical input, author and review annual reports to regulatory agencies, and maintain awareness of regulatory best practices
Influence and implement the network technical agenda and drive continuous improvement with appropriate change controls
Maintain peptide/oligonucleotide processes in a state of compliance with US and global regulations
Provide technical support for technical transfer, process stewardship, and process monitoring at external contract manufacturing groups to achieve reliable and compliant manufacture to global quality standards
Interact daily with external partners, process team members, and site management

Skills

cGMP

Technical Transfer

Process Stewardship

Process Monitoring

API Manufacturing

Peptides

Oligonucleotides

Manufacturing Sciences

Regulatory Compliance

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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