TSMS-API Manufacturing Support Scientist at Eli Lilly and Company

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Strong understanding of pharmaceutical manufacturing principles
Knowledge of cGMPs and applicable global regulatory manufacturing guidance
Familiarity with corporate/industry standards
Ability to work cross-functionally within the site and other functions
Scientific understanding of chemical and equipment interactions relevant to manufacturing intermediates and drug substances

Responsibilities

Providing technical oversight and stewardship for manufacturing processes
Ensuring process compliance with US and global regulations, and maintaining validated or qualified states
Preparing and supporting technical transfer documents
Understanding scientific principles for manufacturing intermediates and drug substances
Leading resolution of technical issues, including control strategy and manufacturing challenges
Executing technical projects to improve process control, yield, purity, and/or productivity
Serving as a liaison between the IPT (Internal Project Team) and CM (Contract Manufacturing) process team
Supporting the manufacture of API intermediates and bulk drug substances

Skills

Key technologies and capabilities for this role

cGMPPharmaceutical ManufacturingAPI ManufacturingTechnical TransferProcess ControlRegulatory ComplianceProcess ValidationChemical ProcessesEquipment InteractionsCross-Functional Collaboration

Questions & Answers

Common questions about this position

Is this position remote or onsite?

This is an onsite position at a Contract Manufacturer site.

What is the salary for this role?

This information is not specified in the job description.

What key skills are required for this position?

Required skills include a strong understanding of pharmaceutical manufacturing principles, knowledge of cGMPs and global regulatory guidance, familiarity with corporate/industry standards, ability to work cross-functionally, and scientific understanding of chemical and equipment interactions in manufacturing.

What is the company culture like at Eli Lilly?

Eli Lilly focuses on putting people first and is determined to make life better for people around the world, as a global healthcare leader with a mission to unite caring with discovery.

What makes a strong candidate for this role?

A strong candidate will have expertise in pharmaceutical manufacturing, cGMPs, regulatory guidance, cross-functional collaboration skills, and scientific knowledge of chemical processes for drug substances.

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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